FDA Oncology Drug Approvals Granted Between August 2016 and May 18, 2017


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Pembrolizumab (Keytruda), an anti–programmed cell death protein 1 (PD-1) therapy, received regular approval from the U.S. Food and Drug Administration (FDA) 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. The FDA also granted approval to pembrolizumab in the first-line setting for patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin. May 18, 2017

  • In earlier FDA actions between August 2016 and May 2017, pembrolizumab was approved in combination with pemetrexed (Alimta) and carboplatin for the first-line treatment of metastatic nonsquamous non–small cell lung cancer, irrespective of programmed death-ligand 1 (PD-L1) expression. May 10, 2017
  • Pembrolizumab was approved for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma or those who have relapsed after three or more prior lines of therapy. March 15, 2017
  • Pembrolizumab was approved for the treatment of patients with metastatic non–small cell lung cancer whose tumors express PD-L1 as determined by an FDA-approved test. October 24, 2016
  • Pembrolizumab was approved for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy. August 5, 2016

Avelumab (Bavencio), an anti–PD-L1 antibody received FDA approval 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

Avelumab also received FDA approval for the treatment of patients 12 years and older with metastatic Merkel cell carcinoma (MCC). March 23, 2017

Durvalumab (Imfinzi), an anti–PD-L1 antibody, received accelerated approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. May 1, 2017

Brigatinib (Alunbrig tablets), a small-molecule targeted cancer therapy, with activity against anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR), received FDA approval for the treatment of patients with metastatic ALK-positive non–small cell lung cancer who have progressed on or are intolerant to crizotinib (Xalkori). April 28, 2017

Midostaurin (Rydapt), a kinase inhibitor, received FDA approval for the treatment of adult patients with newly diagnosed acute myeloid leukemia who are FLT3 mutation-positive), as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. April 28, 2017

FDA expanded the indications of regorafenib (Stivarga), a multikinase inhibitor, to include the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib (Nexavar). April 27, 2017

The ipsogen JAK2 RGQ PCR Kit, a qualitative in vitro diagnostic test for the detection of the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood, was granted marketing authorization by FDA to detect mutations affecting the JAK2 gene. This is the first FDA-authorized test intended to help physicians in evaluating patients for suspected polycythemia vera. March 27, 2017.

Palbociclib (Ibrance), a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, received FDA approval for the treatment of hormone receptor–positive, HER2–negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women. March 31, 2017

Osimertinib (Tagrisso), a third-generation tyrosine kinase inhibitor, received FDA approval for the treatment of patients with metastatic EGFR T790M mutation–positive non–small cell lung cancer, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor therapy. March 30, 2017

Niraparib (Zejula), a poly ADP-ribose polymerase (PARP) inhibitor, received FDA approval for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. March 27, 2017

Ribociclib (Kisqali), a CDK 4/6 inhibitor, received FDA approval in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor–positive, HER2–negative advanced or metastatic breast cancer. March 13, 2017

Lenalidomide (Revlimid), an antiangiogenic agent, received FDA approval as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant. February 22, 2017

Nivolumab (Opdivo), a PD-1 monoclonal antibody, received FDA approval 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;

  • In earlier actions, nivolumab received FDA approval for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy. November 10, 2016
  • FDA modified the dosage regimen for nivolumab for the currently approved indications for renal cell carcinoma, metastatic melanoma, and non–small cell lung cancer. The currently approved recommended dosage regimens were modified to 240 mg intravenously every 2 weeks. September 13, 2016

Rucaparib (Rubraca), a PARP inhibitor received FDA approval 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

Daratumumab (Darzalex), a monoclonal antibody, received FDA approval in combination
with lenalidomide and dexamethasone, or bortezomib (Velcade) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. November 21, 2016

Olaratumab (Lartruvo), a monoclonal antibody, received FDA approval for the treatment of patients with soft-tissue sarcoma not amenable to curative treatment with radiotherapy or surgery and with a histologic subtype for which an anthracycline-containing regimen is appropriate. October 19, 2016

Atezolizumab (Tecentriq), an anti–PD-L1 antibody, received FDA approval for the treatment of patients with metastatic non–small cell lung cancer whose disease progressed during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving atezolizumab.
October 18, 2016

The FDA modified the indication for erlotinib (Tarceva), an EGFR inhibitor for treatment of non–small cell lung cancer, to limit use to patients whose tumors have specific EGFR mutations. October 18, 2016

The co-packaging of ribociclib (Kisqali) and letrozole tablets received approval from the FDA for the treatment of hormone receptor–positive, HER2–negative advanced or metastatic breast cancer in postmenopausal women. The ribociclib/letrozole co-pack is the first—and only currently available—combination pack with two prescription products in advanced breast cancer. May 8, 2017



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