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FDA Approvals
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Food and Drug Administration approved the combination of nivolumab (Opdivo, Bristol-Myers Squibb Co.) and cabozantinib (Cabometyx, Exelixis) as first-line treatment for patients with advanced renal cell carcinoma (RCC). January 22, 2021. More Information:
On January 15, 2021, the Food and Drug Administration granted accelerated approval to daratumumab plus hyaluronidase (Darzalex Faspro, Janssen Biotech Inc.) in combination with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed light chain (AL) amyloidosis.
More Information: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-darzalex-faspro-newly-diagnosed-light-chain-amyloidosis
On January 15, 2021, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
More information: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-fam-trastuzumab-deruxtecan-nxki-her2-positive-gastric-adenocarcinomas
On January 14, 2021, the Food and Drug Administration approved crizotinib (Xalkori, Pfizer Inc.) for pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. The safety and efficacy of crizotinib have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. More Information: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-crizotinib-children-and-young-adults-relapsed-or-refractory-systemic-anaplastic-large
Food and Drug Administration approved osimertinib (TAGRISSO, AstraZeneca Pharmaceuticals LP) for adjuvant therapy after tumor resection in patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. More information. December 18, 2020
Food and Drug Administration approved selinexor (XPOVIO, Karyopharm Therapeutics Inc.) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. More information. December 18, 2020
Food and Drug Administration approved the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist, relugolix, (ORGOVYX, Myovant Sciences, Inc.) for adult patients with advanced prostate cancer. More information. December 18, 2020
Food and Drug Administration approved pralsetinib (GAVRETO, Blueprint Medicines Corporation) for adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy or RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). December 1, 2020. More Information:
Food and Drug Administration approved the Sonalleve MR-HIFU system (Profound Medical Inc.) for the treatment of osteoid osteoma in the extremities. November 27, 2020. More Information:
https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-device-treatment-osteoid-osteoma-extremitiesFood and Drug Administration granted accelerated approval to naxitamab (DANYELZA, Y-mAbs Therapeutics, Inc.) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for pediatric patients one year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow demonstrating a partial response, minor response, or stable disease to prior therapy. November 24, 2020. More Information:
FDA grants accelerated approval to pembrolizumab for locally recurrent unresectable or metastatic triple negative breast cancer. November 13, 2020
Food and Drug Administration approved the liquid biopsy next-generation sequencing-based FoundationOne Liquid CDx test (Foundation Medicine, Inc.) as a companion diagnostic device for multiple additional biomarkers detected in cell free-DNA isolated from plasma specimens. October 26, 2020 and November 6, 2020. More Information:
On October 16, 2020, the Food and Drug Administration granted regular approval to venetoclax (VENCLEXTA ®, AbbVie Inc. and Genentech Inc.) in combination with azacitidine, decitabine, or low-dose cytarabine (LDAC) for newly-diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities precluding intensive induction chemotherapy.
Venetoclax was initially granted accelerated approval for this indication in November 2018.
https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-regular-approval-venetoclax-combination-untreated-acute-myeloid-leukemia
Food and Drug Administration granted accelerated approval to pralsetinib (GAVRETOTM, Blueprint Medicines Corporation) for adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. More information. September 4, 2020.
On September 1, 2020, the Food and Drug Administration approved azacitidine tablets (ONUREG®, Celgene Corporation) for continued treatment of patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy. More information.
Food and Drug Administration approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline) for adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. More Information. August 5, 2020.
FDA granted accelerated approval to tafasitamab-cxix (MONJUVI, MorphoSys US Inc.), a CD19-directed cytolytic antibody, indicated in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant. July 31, 2020. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-tafasitamab-cxix-diffuse-large-b-cell-lymphoma
Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. More Information. July 30, 2020.
Food and Drug Administration granted accelerated approval to brexucabtagene autoleucel (TECARTUS, Kite, a Gilead Company), a CD19-directed genetically modified autologous T cell immunotherapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). More Information. July 24, 2020
Food and Drug Administration approved an oral combination of decitabine and cedazuridine (INQOVI, Astex Pharmaceuticals, Inc.) for adult patients with myelodysplastic syndromes (MDS) including the following: More Information. July 7, 2020
Food and Drug Administration approved avelumab (BAVENCIO, EMD Serono, Inc.) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. More Information. June 30, 2020
Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. More Information. June 29, 2020
Food and Drug Administration approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase–zzxf (PHESGO, Genentech, Inc.) More Information. June 29, 2020.
Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation More Information. June 24, 2020
Food and Drug Administration granted accelerated approval to selinexor (XPOVIO, Karyopharm Therapeutics) for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. More Information. June 22, 2020
Food and Drug Administration granted accelerated approval to tazemetostat (TAZVERIK, Epizyme, Inc.), an EZH2 inhibitor, for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, and for adult patients with R/R FL who have no satisfactory alternative treatment options. More Information. June 18, 2020
https://www.fda.gov/drugs/fda-granted-accelerated-approval-tazemetostat-follicular-lymphoma
Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. More Information. June 16, 2020
Food and Drug Administration extended the indication of gemtuzumab ozogamicin (MYLOTARGTM, Wyeth Pharmaceuticals LLC) for newly-diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric patients 1 month and older. More Information. June 16, 2020
Food and Drug Administration granted accelerated approval to lurbinectedin (ZEPZELCA, Pharma Mar S.A.) for adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. More Information. June 15, 2020
Food and Drug Administration approved nivolumab (OPDIVO, Bristol-Myers Squibb Co.) for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. More Information. June 10, 2020
Food and Drug Administration approved ramucirumab (CYRAMZA, Eli Lilly and Company) in combination with erlotinib for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. More Information. May 29, 2020
Food and Drug Administration approved atezolizumab in combination with bevacizumab (TECENTRIQ and AVASTIN, Genentech Inc.) for patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy. More Information. May 29, 2020
Food and Drug Administration approved the combination of nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co.) and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. More Information. May 26, 2020
Food and Drug Administration approved brigatinib (Takeda Pharmaceuticals) for adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. May 22, 2020
Food and Drug Administration approved olaparib (LYNPARZA, AstraZeneca Pharmaceuticals, LP) for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC), who have progressed following prior treatment with enzalutamide or abiraterone. More Information. May 19, 2020
Food and Drug Administration approved atezolizumab (TECENTRIQ®, Genentech Inc.) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), with no EGFR or ALK genomic tumor aberrations. More information. May 18, 2020
Food and Drug Administration approved ripretinib (QINLOCK, Deciphera Pharmaceuticals, LLC.), for adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. May 15, 2020
Food and Drug Administration granted accelerated approval to rucaparib (RUBRACA, Clovis Oncology, Inc.) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. May 15, 2020
Food and Drug Administration approved the combination of nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co.) as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1(≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. May 15, 2020
ood and Drug Administration expanded the indication of pomalidomide (POMALYST, Celgene Corporation) to include treating adult patients with AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy and Kaposi sarcoma in adult patients who are HIV-negative. May 14, 2020
Food and Drug Administration expanded the indication of olaparib (LYNPARZA®, AstraZeneca Pharmaceuticals, LP) to include its combination with bevacizumab for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability.May 8, 2020
Food and Drug Administration granted accelerated approval to selpercatinib (RETEVMO, Eli Lilly and Company) for the following indications: • Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); • Adult and pediatric patients ≥12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy; • Adult and pediatric patients ≥12 years of age with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). May 8, 2020
Food and Drug Administration granted accelerated approval to capmatinib (TABRECTA, Novartis) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. May 6, 2020
Food and Drug Administration approved daratumumab and hyaluronidase-fihj (DARZALEX FASPRO, Janssen Biotech, Inc.) for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. This new product allows for subcutaneous dosing of daratumumab. May 1, 2020 https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-daratumumab-and-hyaluronidase-fihj-multiple-myeloma
Food and Drug Administration approved niraparib (ZEJULA, GlaxoSmithKline) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. April 29, 2020 https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-niraparib-first-line-maintenance-advanced-ovarian-cancer
Food and Drug Administration granted accelerated approval to sacituzumab govitecan-hziy (TRODELVY, Immunomedics, Inc.) for adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease. April 22, 2020 https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-sacituzumab-govitecan-hziy-metastatic-triple-negative-breast-cancer
Food and Drug Administration expanded the indication of ibrutinib (IMBRUVICA, Pharmacyclics LLC) to include its combination with rituximab for the initial treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). April 21, 2020
Food and Drug Administration granted accelerated approval to pemigatinib (PEMAZYRE, Incyte Corporation) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. April 20, 2020
Food and Drug Administration approved tucatinib (TUKYSA, Seattle Genetics, Inc.) in combination with trastuzumab and capecitabine, for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. April 17, 2020
Food and Drug Administration approved mitomycin (JELMYTO™, UroGen Pharma) for adult patients with low-grade upper tract urothelial cancer (LG-UTUC). April 15, 2020
Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca) for pediatric patients, 2 years of age and older, with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).April 13, 2020
Food and Drug Administration approved encorafenib (BRAFTOVI, Array BioPharma Inc.) in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, detected by an FDA-approved test, after prior therapy.
Food and Drug Administration approved luspatercept-aamt (REBLOZYL, Celgene Corporation) for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T). April 3, 2020
Food and Drug Administration approved durvalumab (IMFINZI, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). More Information. March 30, 2020
Food and Drug Administration approved isatuximab-irfc (SARCLISA, sanofi-aventis U.S. LLC) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. More Information. March 2, 2020
On February 25, 2020, the Food and Drug Administration approved neratinib (NERLYNX, Puma Biotechnology, Inc.) in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.
Food and Drug Administration granted accelerated approval to tazemetostat (TAZVERIK, Epizyme, Inc.) for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. More Information. January 23, 2020
Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co. Inc.) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. More Information. January 8, 2020
Food and Drug Administration approved olaparib (LYNPARZA®, AstraZeneca Pharmaceuticals LP) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma, as detected by an FDA-approved test, whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. More Information. December 27, 2019.
Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (ENHERTU®, Daiichi Sankyo) for patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. More Information. December 20, 2019
FDA granted accelerated approval to enfortumab vedotin-ejfv (PADCEV, Astellas Pharma US, Inc.) for adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. December 18, 2019
FDA approved atezolizumab (TECENTRIQ, Genentech Inc.) in combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. December 3, 2019
FDA granted accelerated approval to voxelotor (Oxbryta, Global Blood Therapeutics) for adults and pediatric patients 12 years of age and older with sickle cell disease. November 25, 2019 https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-voxelotor-sickle-cell-disease
FDA approved acalabrutinib (CALQUENCE, AstraZeneca) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). November 21, 2019
FDA approved crizanlizumab-tmca (ADAKVEO, Novartis) to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease.
November 15, 2019 https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-crizanlizumab-tmca-sickle-cell-disease
FDA granted accelerated approval to zanubrutinib (BRUKINSA, BeiGene, Ltd.) for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. November 14, 2019 https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanubrutinib-mantle-cell-lymphoma
FDA approved luspatercept-aamt (REBLOZYL, Celgene Corp.) for treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions. November 8, 2019 https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-luspatercept-aamt-anemia-patients-beta-thalassemia
On October 23, 2019, the Food and Drug Administration approved niraparib (ZEJULA®, Tesaro, Inc.) for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status. HRD is defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability in patients with disease progression greater than six months after response to the last platinum-based chemotherapy.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208447s014lbl.pdf
FDA approved daratumumab (DARZALEX, Janssen) for adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant (ASCT). More Information. September 26, 2019
FDA approved apalutamide (ERLEADA, Janssen Biotech, Inc) for patients with metastatic castration-sensitive prostate cancer (mCSPC). Apalutamide was initially approved in 2018 for patients with non-metastatic castration-resistant prostate cancer. More Information. September 17, 2019
FDA granted accelerated approval to the combination of pembrolizumab (KEYTRUDA, Merck) plus lenvatinib (LENVIMA, Eisai) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation. More Information. September 17, 2019
FDA approved fedratinib (INREBIC, Impact Biomedicines, Inc.) for adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). More Information. August 16, 201915, 2019.
On July 3, 2019, the Food and Drug Administration granted accelerated approval to selinexor (XPOVIO, Karyopharm Therapeutics) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-selinexor-multiple-myeloma
FDA approved daratumumab (DARZALEX, Janssen Biotech, Inc.) in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. More Information. June 27,2019.
FDA approved alpelisib (PIQRAY, Novartis Pharmaceuticals Corporation) in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. More Information. May 24, 2019
FDA approved ruxolitinib (JAKAFI, Incyte Corporation) for steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older. More Information. May 24, 2019
FDA approved dalteparin sodium (FRAGMIN, Pfizer, Inc.) to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients 1 month of age and older. More Information. May 16, 2019
FDA approved approved venetoclax (VENCLEXTA, AbbVie Inc. and Genentech Inc.) for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)..More Information. May 15, 2019 https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-venetoclax-cll-and-sll
FDA approved avelumab (BAVENCIO, EMD Serono, Inc.) in combination with axitinib for first-line treatment of patients with advanced renal cell carcinoma (RCC). More Information. May 14, 2019 https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-avelumab-plus-axitinib-renal-cell-carcinoma
FDA approved ramucirumab (CYRAMZA, Eli Lilly and Company) as a single agent for hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein (AFP) of ≥ 400 ng/mL and have been previously treated with sorafenib. More Information. May 10, 2019
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ramucirumab-hepatocellular-carcinomahttps://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ramucirumab-hepatocellular-carcinoma
On May 3, 2019, the Food and Drug Administration approved ado-trastuzumab emtansine (KADCYLA, Genentech, Inc.) for the adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.
FDA approved pembrolizumab (KEYTRUDA, Merck & Co. Inc.) plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC).More Information, April 19, 2019
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm636395.htmThe FDA has expanded the approval of palbociclib (Ibrance) capsules in combination with endocrine therapy for male patients with hormone receptor (HR)–positive, HER2-negative advanced or metastatic breast cancer.
Full updated prescribing information.
FDA approved atezolizumab (TECENTRIQ, Genentech Inc.) in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). March 18, 2019
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm633814.htm
FDA approves atezolizumab for PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer. More information. March 8, 2019
On February 28, 2019, the Food and Drug Administration approved trastuzumab and hyaluronidase-oysk injection,for subcutaneous use (Herceptin Hylecta, Genentech Inc.). Herceptin Hylecta is a combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase, for the treatment of HER2‑overexpressing breast cancer.
FDA approved trifluridine/ tipiracil tablets (LONSURF, Taiho Pharmaceutical Co., Ltd.)—a fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor—for adult patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. More Information. February 22, 2019.
On February 15, 2019, the Food and Drug Administration approved pembrolizumab (KEYTRUDA®, Merck) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
Approval was based on EORTC1325/KEYNOTE‑054 (NCT02362594), a randomized, double-blind, placebo-controlled, trial in 1019 patients with completely resected, stage IIIA (>1 mm lymph node metastasis), IIIB or IIIC melanoma (AJCC 7th ed). Patients with mucosal or ocular melanoma were not eligible. Patients were randomly allocated (1:1) to receive pembrolizumab 200 mg every three weeks or placebo for up to 1 year until disease recurrence or unacceptable toxicity. Enrollment required complete resection of melanoma with negative margins, lymph node dissection, and completion of radiotherapy, if indicated, within 13 weeks prior to starting treatment.
FDA approves ibrutinib in combination with gazyva for CLL/SLL in previously untreated patients
The FDA has approved ibrutinib (Imbruvica; AbbVie) for use in combination with obinutuzumab (Gazyva; Genentech) for the treatment of adults with untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This approval was based on results from the phase 3 iLLUMINATE clinical trial of treatment-naïve patients with CLL or SLL.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205552s026,210563s002lbl.pdf
FDA approves pembrolizumab for Merkel cell carcinoma
On December 19, 2018, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co. Inc.) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC)
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm628867.htm
FDA approves atezolizumab in combination with bevacizumab
FDA approved atezolizumab (TECENTRIQ, Genentech, Inc.), in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic non-squamous, non-small cell lung cancer (NSq NSCLC) with no EGFR or ALK genomic tumor aberrations. More Information . December 6, 2018
FDA approves gilteritinib for relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation
November 28, 2018 FDA approved gilteritinib (XOSPATA, Astellas Pharma US Inc.) for treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.
FDA approves venetoclax in combination for AML in adults
November 21, 2018 FDA granted accelerated approval to venetoclax (VENCLEXTA, AbbVie Inc. and Genentech Inc.) in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
FDA Approves New Immunotherapy Combination
November 6, 2018 - U.S. Food and Drug Administration Approves Empliciti® (elotuzumab) Plus Pomalidomide and Dexamethasone, a New Immunotherapy Combination for Certain Patients with Relapsed or Refractory Multiple Myeloma
FDA approves biosimilar Udenyca (pegfilgrastim-cbqv)
November 2, 2018 - the U.S. Food and Drug Administration (FDA) has approved UDENYCATM
(pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved by both the FDA and the
European Commission (EC) for patients with cancer receiving myelosuppressive chemotherapy.
FDA approves pembrolizumab in combination with chemotherapy for first-line treatment of metastatic squamous NSCLC
On October 30, 2018, the Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co. Inc.) in combination with carboplatin and either paclitaxel or nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC).
FDA approves talazoparib for gBRCAm HER2-negative locally advanced or metastatic breast cancer
On October 16, 2018, the Food and Drug Administration approved talazoparib (TALZENNA, Pfizer Inc.), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib.
FDA approves dacomitinib for metastatic non-small cell lung cancer
FDA approved dacomitinib tablets (VIZIMPRO, Pfizer Pharmaceutical Company) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. September 27, 2018
The U.S. Food and Drug Administration (FDA) has approved ibrutinib (Imbruvica) plus rituximab (Rituxan) for the treatment of adult patients with Waldenström's macroglobulinemia (WM). With this approval, the ibrutinib prescribing information now includes combination use with rituximab, representing the first and only chemotherapy-free combination treatment specifically indicated for the disease. Ibrutinib— a first-in-class Bruton's tyrosine kinase (BTK) inhibitor—was first approved as a single agent therapy for WM in January 2015.
FDA approves moxetumomab pasudotox-tdfk for HCL
FDA approved moxetumomab pasudotox-tdfk (LUMOXITI, AstraZeneca Pharmaceuticals LP), a CD22-directed cytotoxin indicated for adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA). More Information.
September 13, 2018
On August 20, 2018, the Food and Drug Administration approved pembrolizumab (KEYTRUDA®, Merck & Co., Inc.) in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer (NSqNSCLC), with no EGFR or ALK genomic tumor aberrations.
FDA expanded the indication for ribociclib (Kisqali, Novartis Pharmaceuticals Corporation) in combination with an aromatase inhibitor for pre/perimenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. July 18, 2018
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm613803.html
On July 13, 2018, the Food and Drug Administration approved enzalutamide (XTANDI, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC). This approval broadens the indicated patient population to include patients with both non-metastatic CRPC (NM-CRPC) and metastatic CRPC. Enzalutamide was previously approved for the treatment of patients with metastatic CRPC.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm613543.htm
On July 10, 2018, the Food and Drug Administration granted accelerated approval to ipilimumab (YERVOY®, Bristol-Myers Squibb Company Inc.) for use in combination with nivolumab for the treatment of patients 12 years of age and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
This new use has also been added to the OPDIVO (nivolumab) labeling. Nivolumab received accelerated approval for this indication as a single agent on July 31, 2017.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm610670.htm
FDA approved bevacizumab (Avastin, Genentech, Inc.) for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection. More Information. June 13, 2018
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm610664.htm
FDA approves Venetoclax
On June 8, 2018, the FDA granted regular approval to venetoclax (VENCLEXTA, AbbVie Inc. and Genentech Inc.) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm610308.htm
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm607723.htm
FDA approves tisagenlecleucel for adults with relapsed or refractory large B-cell lymphoma
FDA approved tisagenlecleucel (KYMRIAH, Novartis Pharmaceuticals Corp.) a CD19-directed genetically modified autologous T-cell immunotherapy, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. May 1, 2018.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm606540.htm
FDA approves dabrafenib plus trametinib for adjuvant treatment of melanoma with BRAF V600E or V600K mutations
FDA granted regular approval to dabrafenib (TAFINLAR, Novartis Pharmaceuticals Corp.) and trametinib (MEKINIST, Novartis Pharmaceuticals Corp.) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. April 30, 2018https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm606165.htm
FDA approves osimertinib for first-line treatment of metastatic NSCLC with most common EGFR mutations
FDA approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. April 19, 2018.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm605113.htm
On April 16, 2018, the Food and Drug Administration granted approvals to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb Co.) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm604685.htm
FDA approves rucaparib for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer
On April 6, 2018, the Food and Drug Administration approved rucaparib (Rubraca®, Clovis Oncology Inc.), a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm603997.htm
FDA approved brentuximab vedotin (Adcetris, Seattle Genetics, Inc.) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy. More Information. March 20, 2018 https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm601947.htm
3/6/18
The U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the Opdivo ® (nivolumab) dosing schedule to include 480 mg infused every four weeks (Q4W) for a majority of approved indications.1 This approval will provide health care professionals the flexibility to customize patient care with the option of using the newly approved Q4W (480 mg) flat dose in addition to the previously available option of every two weeks (Q2W) at 240 mg, now available in a new 240 mg vial.1 Opdivo also was approved for a shorter 30-minute infusion across all approved indications.1 Dosing schedule updates for an additional approvedindication for Opdivo may be submitted to the FDA in the future.
https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibbs-opdivo-nivolumab-now-first-and-only-fda-
FDA approves abemaciclib
On February 26, 2018, the Food and Drug Administration approved abemaciclib (VERZENIO™, Eli Lilly and Company) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. 2/26/18
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm598404.htm
The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation). (2/16/18)
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm601947.htm
FDA approves abiraterone acetate in combination with prednisone for high-risk metastatic castration-sensitive prostate cancer
FDA approved abiraterone acetate (Zytiga, Janssen Biotech Inc.) tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC). More Information. February 7, 2018FDA approves sunitinib malate for adjuvant treatment of renal cell carcinoma
FDA approved sunitinib malate (Sutent, Pfizer Inc.) for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy. More Information. November 16, 2017
FDA approves a new first line indication for obinutuzumab
On November 16, 2017, GAZYVA® (obinutuzumab), in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, was approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma (FL). The FDA approval letter can be found at https://www.genentech-access.com/gazyva.html.
FDA approves first treatment for certain patients with Erdheim-Chester Disease, a rare blood cancer
The U.S. Food and Drug Administration today expanded the approval of Zelboraf (vemurafenib) to include the treatment of certain adult patients with Erdheim-Chester Disease (ECD), a rare cancer of the blood. Zelboraf is indicated to treat patients whose cancer cells have a specific genetic mutation known as BRAF V600. This is the first FDA-approved treatment for ECD.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583931.htm
On September 22, 2017, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test. Patients must have had disease progression on or after two or more prior systemic therapies, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm577093.htm
FDA grants accelerated approval to Opdivo for the Treatment of Hepatocellular Carcinoma Patients Previously Treated with Sorafenib
9/22/17 - The U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection for intravenous use for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Approval for this indication has been granted under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.1 In the CheckMate -040 trial, 14.3%* (95% CI: 9.2-20.8; 22/154) of patients responded to treatment with Opdivo. The percentage of patients with a complete response was 1.9% (3/154) and the percentage of patients with a partial response was 12.3% (19/154).1 Among responders (n=22), responses ranged from 3.2 to 38.2+ months; 91% of those patients had responses of six months or longer and 55% had responses of 12 months or longer.1
FDA Approves Aliqopa™ (copanlisib) for the treatment of adult patients with relapsed FL who have received at least two prior systemic therapies.
9/14/17 The U.S. Food and Drug Administration granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm576129.htm
FDA Approves Gemtuzumab Ozogamicin for Treatment of Acute Myeloid Leukemia
The U.S. Food and Drug Administration (FDA) today approved gemtuzumab ozogamicin (Mylotarg) for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) whose tumors express the CD33 antigen. The drug was also approved for the treatment of patients aged 2 years and older with relapsed or refractory CD33-positive AML.
http://www.ascopost.com/News/57996
FDA approval brings first gene therapy to the United States
CAR T-cell therapy approved to treat certain children and young adults with B-cell acute lymphoblastic leukemia
The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases. (8/30/17)
The FDA approved Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL).
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm574058.htm
FDA approved inotuzumab ozogamicin (BESPONSA,, Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). August 17, 2017. More Information: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm572133.htm
FDA approves treatment for chronic graft versus host disease
The U.S. Food and Drug Administration today expanded the approval of Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments. This is the first FDA-approved therapy for the treatment of cGVHD.
FDA granted accelerated approval to nivolumab (OPDIVO, Bristol-Myers Squibb Company) for the treatment of patients 12 years and older with mismatch repair deficient (dMMR) and microsatellite instability high (MSI-H) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. August 1, 2017. More Information: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm569366.htm
FDA approves rituximab plus hyaluronidase combination
FDA granted regular approval to the combination of rituximab and hyaluronidase human (RITUXAN HYCELA, Genentech Inc.) for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. June 22, 2017. https://www.fda.gov/Drugs/
FDA approves ceritinib for NSCLC
FDA granted regular approval to ceritinib (ZYKADIA, Novartis Pharmaceuticals Corp.) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. More Information. May 26, 2017
FDA grants accelerated approval to pembrolizumab for first tissue/site agnostic indication
FDA granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co.) for adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or with MSI-H or dMMR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. May 23, 2017.
More Information: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm560040.htm
Pebrolizumab (Keytruda): Advanced or Metastatic Urothelial Carcinoma
On May 18, 2017, the U.S. FDA granted regular approval to pembrolizumab (KEYTRUDA, Merck and Co., Inc.) for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. . More Information: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm559300.htm
FDA grants accelerated approval to pembrolizumab for NSCLC
On May 10, 2017, the U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA®, Merck and Co., Inc.) in combination with pemetrexed and carboplatin for the treatment of patients with previously untreated metastatic non-squamous non-small cell lung cancer (NSCLC). More information.
FDA grants accelerated approval to avelumab for urothelial carcinoma
The U.S. Food and Drug Administration granted accelerated approval to avelumab (BAVENCIO, EMD Serono, Inc.) for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. May 9, 2017 More Information: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm557162.htm
FDA approves brigatinib
On April 28, 2017, the U.S. Food and Drug Administration granted accelerated approval to brigatinib (ALUNBRIG tablets, Takeda Pharmaceutical Company Limited, through its wholly owned subsidiary ARIAD Pharmaceuticals, Inc.) for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm555841.htm
FDA approves atezolizumab
The FDA approved Tecentriq (atezolizumab) as a first-line treatment for people with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin chemotherapy. The Genentech press release including Important Safety Information is linked here.
FDA Approves avelumab
U.S. Food and Drug Administration granted accelerated approval to avelumab (BAVENCIO, EMD Serono, Inc.) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). Avelumab is a programmed death-ligand 1 (PD-L1) blocking human IgG1 lambda monoclonal antibody. This is the first FDA-approved product to treat this type of cancer. March 23, 2017. More Information: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm547965.htm
FDA Approves pembrolizumab
The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA), Merck and Co., Inc.) for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior lines of therapy. March 14, 2017.
More Information: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm546893.htm
FDA Approves ribociclib
FDA approved ribociclib (KISQALI, Novartis Pharmaceuticals Corp.), a cyclin-dependent kinase 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. March 13, 2017.
More Information: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm546438.htm
FDA Approves lenalidomide
FDA approved lenalidomide (Revlimid, Celgene Corp.) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant. February 22, 2017. More Information: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm542791.htm
FDA Approves Nivolumab for Treatment of Urothelial Carcinoma
February 2, 2017, the U.S. FDA granted accelerated approval to nivolumab (OPDIVO, Bristol-Myers Squibb Company) for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy. February 2, 2017. More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm539646.htm
FDA Approves ibrutinib for MZL
January 19, 2017, the U.S. Food and Drug Administration (FDA) approved Imbruvica (ibrutinib) for the treatment of patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.1 This indication is approved under accelerated approval based on overall response rate (ORR), and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.
https://www.drugs.com/newdrugs/u-s-fda-approves-imbruvica-ibrutinib-first-specifically-indicated-relapsed-refractory-marginal-zone-4476.html
FDA Approves rucaparib
FDA granted accelerated approval to rucaparib (RUBRACA, Clovis Oncology, Inc.) for treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies. December 19, 2016. More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm533891.htm
FDA Approves Avastin in combination with chemotherapy for psOC
The FDA granted approval to Avastin in combination with chemotherapy for the treatment of platinum-sensitive recurrent ovarian cancer (psOC), representing the first new treatment option for women with psOC in the U.S. in more than a decade [press release].
Ovarian cancer causes more deaths than any other gynecological cancer in the U.S., and in 2016, about 22,200 women will be diagnosed with ovarian cancer in the U.S. and about 14,200 will die from the disease. Women with ovarian cancer are considered to have “platinum-sensitive” disease if a relapse occurs six months or longer following the last treatment with a platinum-based chemotherapy. About half of those who relapse after initial treatment – over 8,000 women – will have psOC.
With today’s approval, Avastin is now approved in the U.S. for nine distinct uses across six different types of cancer including two types of gynecological cancer.