In cooperation with the Food and Drug Administration (FDA), and as a service to our members, NNECOS will periodically distribute information about newly approved therapies for cancer patients.  This helps FDA to inform oncologists and professionals in oncology-related fields of recent approvals in a timely manner.  Please note the link to the FDA information providing relevant clinical information, contraindications, dosing, and safety.  In providing this information, NNECOS does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described. If you have questions about billing or reimbursement for these drugs, we recommend that you visit our Regional Reimbursement Page to contact a representative of the manufacturer for assistance.

FDA approves tazemetostat for advanced epithelioid sarcoma

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

FDA approved pembrolizumab for the treatment of BCG-unresponsive

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

FDA approves olaparib for gBRCAm metastatic pancreatic adenocarcinoma

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.

FDA approves fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive breast cancer

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 grants accelerated approval to enfortumab vedotin-ejfv for metastatic urothelial cancer

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

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-enfortumab-vedotin-ejfv-metastatic-urothelial-cancer

FDA approves atezolizumab with nab-paclitaxel and carboplatin for metastatic NSCLC without EGFR/ALK aberrations

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

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-nab-paclitaxel-and-carboplatin-metastatic-nsclc-without-egfralk

FDA grants accelerated approval to voxelotor for sickle cell disease

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 approves acalabrutinib for CLL and SLL

FDA approved acalabrutinib (CALQUENCE, AstraZeneca) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). November 21, 2019

https://www.fda.gov/drugs/resources-information-approved-drugs/project-orbis-fda-approves-acalabrutinib-cll-and-sll

FDA approves crizanlizumab-tmca for sickle cell disease

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 grants accelerated approval to zanubrutinib

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 approves luspatercept-aamt

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

FDA approves niraparib

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 approves daratumumab

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 approves apalutamide

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 approves pembrolizumab in combination with lenvatinib

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 approves fedratinib

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.

FDA Approves entrectinib

FDA granted accelerated approval to entrectinib (ROZLYTREK, Genentech Inc.) for adults and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy. More Information August 15, 2019.

FDA grants accelerated approval to selinexor for multiple myeloma

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 approves daratumubab

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 approves pembrolizumab for metastatic small cell lung cancer

FDA granted accelerated approval to pembrolizumab (KEYTRUDA,  Merck) for patients with metastatic small cell lung cancer (SCLC) with disease  progression on or after platinum-based chemotherapy and at least one other prior  line of therapy. More Information  June 17, 2019.

FDA approves pembrolizumab for first-line treatment of head and neck squamous cell carcinoma

FDA approved pembrolizumab (KEYTRUDA, Merck) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC). More Information.  June 10, 2019

FDA approves polatuzumab vedotin-piiq for diffuse large B-cell lymphoma

FDA granted accelerated approval to polatuzumab vedotin-piiq (POLIVY, Genentech, Inc.), a CD79b-directed antibody-drug conjugate indicated in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies. More Information. June 10, 2019

FDA approves addition of survival data to gilteritinib label for refractory AML with a FLT3 mutation

FDA approved the addition of overall survival data in labeling for gilteritinib (XOSPATA, Astellas Pharma US, Inc.), indicated for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. More Information.  May 29, 2019

FDA approves lenalidomide for follicular and marginal zone lymphoma

FDA approved lenalidomide (REVLIMID, Celgene Corp.) in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL). More Information. May 28, 2019

FDA approves alpelisib for metastatic breast cancer

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 approves ruxolitinib for acute graft-versus-host disease

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 approves dalteparin sodium for VTE in pediatric patients

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

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-dalteparin-sodium-vte-pediatric-patients

FDA approves venetoclax for CLL and SLL

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 approves avelumab plus axitinib for renal cell carcinoma

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 approves ramucirumab

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

FDA approves ado-trastuzumab emtansine for early breast cancer

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.

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ado-trastuzumab-emtansine-early-breast-cancer

FDA approves pembrolizumab plus axitinib for advanced renal cell carcinoma

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.htm

FDA Approves Palbociclib for Male Patients With HR+/HER2- Breast Cancer

The 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 approves atezolizumab for extensive-stage small cell lung cancer

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

FDA approves atezolizumab for PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer. More information. March 8, 2019

FDA approves new formulation of Herceptin for subcutaneous use

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. 

https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm632294.htm

FDA approves Lonsurf for recurrent, metastatic gastric and gastroesophageal junction adenocarcinoma

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.

FDA approves pembrolizumab for adjuvant treatment of melanoma

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 7^th 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.

Full prescribing info.

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. 

More information

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.

More Information.

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

More information

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.

More information

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).

More information

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.

More information.

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

FDA Approves Ibrutinib Plus Rituximab for Waldenström’s Macroglobulinemia

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.

More information

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.

Full prescribing info.
FDA grants nivolumab accelerated approval for third-line treatment of metastatic small cell lung cancer

https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm617370.htm
FDA approves lenvatinib for unresectable hepatocellular carcinoma

U.S. FDA Approves Pfizer’s Biosimilar NIVESTYMTM (filgrastim-aafi)

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

FDA approves enzalutamide for castration-resistant prostate cancer

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

FDA grants accelerated approval to ipilimumab for MSI-H or dMMR metastatic colorectal cancer

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.

FDA grants accelerated approval to pembrolizumab

On June 13, 2018, the FDA granted accelerated approval to pembrolizumab (Keytruda, Merck) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy.

https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm610670.htm

FDA approves bevacizumab in combination with carboplatin and paclitaxel

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

FDA approves Retacrit as a biosimilar to Epogen/Procrit

On May 15, 2018, the Food and Drug Administration approved Retacrit (epoetin alfa-epbx, Hospira Inc., a subsidiary of Pfizer Inc.) as a biosimilar to Epogen/Procrit (epoetin alfa, Amgen Inc.) for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, use of zidovudine in patients with HIV infection, and the effects of concomitant myelosuppressive chemotherapy. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery.

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, 2018

https://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

FDA approves nivolumab plus ipilimumab combination for intermediate or poor-risk advanced renal cell carcinoma

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 Approves blinatumomab
FDA granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. More Information.  March 29, 2018

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.

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

FDA Approves Four-Week Dosing Schedule For Nivolumab

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

FDA expands approval of Imfinzi to reduce the risk of non-small cell lung cancer progressing

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, 2018

Second FDA approval for afatinib 

FDA granted approval to afatinib (Gilotrif, Boehringer Ingelheim Pharmaceutical, Inc.) for a broadened indication in first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.   More Information.  January 12, 2018

FDA approves pertuzumab
FDA granted regular approval to pertuzumab (PERJETA, Genentech, Inc.) for use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. More Information.  December 20, 2017FDA approves nivolumab
FDA granted regular approval to the anti-PD1 monoclonal antibody, nivolumab (OPDIVO, Bristol-Myers Squibb Company) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection. Nivolumab was previously approved for the treatment of patients with unresectable or metastatic melanoma. More Information.  December 20, 2017 FDA approves bosutinib
FDA granted accelerated approval to bosutinib (BOSULIF, Pfizer Inc.) for treatment of patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML). More Information.   December 19, 2017 FDA approves cabozantinib
FDA granted regular approval to cabozantinib (Cabometyx, Exelixis, Inc.) for treatment of patients with advanced renal cell carcinoma (RCC). More Information.  December 19, 2017.

FDA 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 dasatinib for pediatric patients with CML
FDA granted regular approval to dasatinib (SPRYCEL, Bristol-Myers Squibb Co.) for the treatment of pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase. More Information. November 9, 2017

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

Alectinib approved for (ALK) positive metastatic non-small cell lung cancer (NSCLC)

FDA granted regular approval to alectinib (ALECENSA, Hoffmann-La Roche, Inc./Genentech, Inc.) for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. More Information.  November 6, 2017 

FDA approves new treatment for certain advanced or metastatic breast cancers

9/28/17 -The U.S. Food and Drug Administration approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones (endocrine therapy). Verzenio is approved to be given in combination with an endocrine therapy, called fulvestrant, after the cancer had grown on endocrine therapy. It is also approved to be given on its own, if patients were previously treated with endocrine therapy and chemotherapy after the cancer had spread (metastasized).https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm578071.htm

FDA grants accelerated approval to pembrolizumab for advanced gastric cancer

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

^{https://www.reuters.com/article/brief-bristol-myers-says-fda-approves-op/brief-bristol-myers-says-fda-approves-opdivo-injection-for-intravenous-use-in-certain-patients-idUSASB0BKMM}

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 approves inotuzumab ozogamicin for relapsed or refractory B-cell precursor ALL

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.

https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm569710.htm

FDA grants nivolumab accelerated approval for MSI-H or dMMR colorectal cancer

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/InformationOnDrugs/ApprovedDrugs/ucm564235.htm

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.

Read more. 

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