FDA Cancer Drug Approvals in 2017

On February 2, the FDA granted accelerated approval to nivolumab (Opdivo) for the 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.

On March 13, the FDA approved ribociclib (Kisqali), 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 advanced or metastatic hormone receptor–positive, HER2-negative breast cancer. Read More

On March 15, the FDA granted accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma, and for those who have relapsed after three or more prior lines of therapy.

On March 23, the FDA granted accelerated approval to avelumab (Bavencio) for the treatment of patients 12 years and older with metastatic Merkel cell carcinoma. This is the first FDA-approved product to treat this type of cancer. Read More

On March 27, the FDA approved niraparib (Zejula), a poly ADP-ribose polymerase (PARP) inhibitor, 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. Read More

On March 31, the FDA granted regular approval to palbociclib (Ibrance) for the treatment of advanced or metastatic hormone receptor–positive, HER2-negative breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women.

On April 17, the FDA expanded its approval of atezolizumab (Tecentriq) for the treatment of advanced bladder cancer. The new indication allows for its use as initial therapy in urothelial carcinoma patients who are not eligible for cisplatin chemotherapy. Read More

On April 28, the FDA approved midostaurin (Rydapt) for the treatment of adult patients with newly diagnosed acute myeloid leukemia who have a FLT3 mutation, as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. Read More

On April 28, the FDA granted accelerated approval to brigatinib (Alunbrig) for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non–small-cell lung cancer who have progressed on or are intolerant to crizotinib. Read More

On May 1, the FDA granted accelerated approval to durvalumab (Imfinzi) 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. Read More

On May 9, the FDA granted accelerated approval to avelumab (Bavencio) 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. Read More

On May 23, the FDA granted accelerated approval to pembrolizumab (Keytruda) for adult and pediatric patients with unresectable or metastatic, microsatellite instability–high or mismatch repair–deficient solid tumors that have progressed after prior treatment and who have no satisfactory alternative treatment options. Pembrolizumab also received approval for patients with microsatellite instability–high or mismatch repair–deficient colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Read More

On June 16, the FDA approved the combination of daratumumab (Darzalex) with pomalidomide and dexamethasone for the treatment of multiple myeloma. Patients with relapsed or refractory myeloma who have had at least two prior therapies including lenalidomide and a proteasome inhibitor are now eligible to receive daratumumab, the first monoclonal antibody to receive approval for treating multiple myeloma. Read More

On June 22, the FDA granted regular approvals to dabrafenib (Tafinlar) and trametinib (Mekinist) administered in combination for patients with metastatic non–small-cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. Read More

On August 1, the FDA granted regular approval to enasidenib (Idhifa) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test. Read More

On August 1, the FDA granted accelerated approval to nivolumab (Opdivo) for the treatment of patients 12 years and older with mismatch repair–deficient and microsatellite instability–high metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Read More

On August 2, the FDA approved ibrutinib (Imbruvica) for the treatment of adults with chronic graft vs host disease (GVHD) after failure of one or more lines of systemic therapy. This is the first FDA-approved therapy for the treatment of chronic GVHD. Read More

On August 17, the FDA granted regular approval to olaparib tablets (Lynparza) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. Read More

On August 30, the FDA granted regular approval to tisagenlecleucel (Kymriah) for the treatment of patients up to age 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Read More

On September 14, the FDA granted accelerated approval to copanlisib (Aliqopa) for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. Read More

On September 22, the FDA granted accelerated approval to nivolumab (Opdivo) for the treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. Read More

On September 22, the FDA granted accelerated approval to pembrolizumab (Keytruda) 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.

On October 31, the FDA granted accelerated approval to acalabrutinib (Calquence) for treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy. Read More

On November 9, the FDA granted regular approval to brentuximab vedotin (Adcetris) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides who have received prior systemic therapy. Read More