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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.
FFDA 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
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
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, 2019FDA 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, 2019FDA 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
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.
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.htmFDA 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 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
FDA Approves duvelisib (COPIKTRA, Verastem, Inc.) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
FDA granted regular approval to duvelisib (COPIKTRA, Verastem, Inc.) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. In addition, duvelisib received accelerated approval for adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. September 24, 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.
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
FDA granted accelerated approval to nivolumab (Opdivo, Bristol-Myers Squibb Company Inc.) for patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. More Information. August 16, 2018
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm617370.htm
FDA approves lenvatinib for unresectable hepatocellular carcinoma
On August 16, 2018, the Food and Drug Administration approved lenvatinib capsules (Lenvima, Eisai Inc.) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Approval was based on an international, multicenter, randomized, open-label, non-inferiority trial (REFLECT; NCT01761266) conducted in 954 patients with previously untreated, metastatic or unresectable HCC. Patients were randomized (1:1) to receive lenvatinib (12 mg orally once daily for patients with a baseline body weight of ≥60 kg and 8 mg orally once daily for patients with a baseline body weight of <60 kg) or sorafenib (400 mg orally twice daily). Treatment continued until radiological disease progression or unacceptable toxicity.
U.S. FDA Approves Pfizer’s Biosimilar NIVESTYMTM (filgrastim-aafi)
the United States (U.S.) Food and Drug Administ ration (FDA) has approved NIVESTYMTM (filgrastim-aafi), a biosimilar to Neupogen 1 (filgrastim), for all eligible indications of the reference product.
“The FDA approval of NIVESTYM marks an important step in helping expand access to critical t reatment options for patients with neutropenia, many of whom have cancer and can be hospitalized for potentially life-threatening side effects stemming from chemotherapy,” said Berk Gurdogan, U.S. Institutions President, Pfizer Essential Health. “We believe biosimilars, like NIVESTYM, are essential in helping to address evolving healthcare needs and may provide more affordable medicines to patients.” The FDA approval was based on a review of a comprehensive data package and totality of evidence demonst rating a high degree of similarity of NIVESTYM compared to its reference product.
“The FDA approval of NIVESTYM marks an important step in helping expand access to critical t reatment options for patients with neutropenia, many of whom have cancer and can be hospitalized for potentially life-threatening side effects stemming from chemotherapy,” said Berk Gurdogan, U.S. Institutions President, Pfizer Essential Health. “We believe biosimilars, like NIVESTYM, are essential in helping to address evolving healthcare needs and may provide more affordable medicines to patients.” The FDA approval was based on a review of a comprehensive data package and totality of evidence demonst rating a high degree of similarity of NIVESTYM compared to its reference product.
FDA expands ribociclib indication in HR-positive, HER2-negative advanced or metastatic breast cancer
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 pembrolizumabOn 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, 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
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 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 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, 2017
FDA approves nivolumabFDA 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 bosutinibFDA 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 cabozantinibFDA 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 CMLFDA 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, 2017FDA 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.htmFDA 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
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/
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.
To submit FDA approvals for posting consideration, forward to info@nnecos.org.
Northern New England Clinical Oncology Society
P.O. Box 643
Sandown, NH 03873-0643
Telephone (603) 887-1948
info@nnecos.org
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