FDA Drug Approvals 2014

FDA Drug Approvals 2014

By The ASCO Post
January 25, 2015, Volume 6, Issue 1



•Nivolumab (Opdivo), a monoclonal antibody, was approved for treatment of metastatic melanoma. Approved December 22, 2014.

•Olaparib (Lynparza), a poly (ADP-ribose) polymerase (PARP) inhibitor, was approved for treatment of BRCA-mutated advanced ovarian cancer. Approved December 19, 2014.

•Lanreotide (Somatuline) depot injection, a somatostatin analog, was approved for treatment of gastroenteropancreatic neuroendocrine tumors. Approved December 16, 2014.

•Ramucirumab (Cyramza) injection, a recombinant monoclonal antibody, was approved for treatment (in combination with docetaxel) of metastatic non–small cell lung cancer. Approved December 12, 2014.

•Ruxolitinib (Jakafi), a Janus-associated kinase (JAK1 and JAK2) inhibitor, was approved for the treatment of polycythemia vera. Approved December 4, 2014.

•Blinatumomab (Blincyto), a bispecfic CD-19 directed CD3 T-Cell engager (BiTE®), was granted accelerated approval for the treatment of relapsed or refractory acute lymphoblastic leukemia. Accelerated approval granted December 3, 2014.

•Bevacizumab (Avastin), a vascular endothelial growth factor–specific angiogenesis inhibitor, was approved for treatment (in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan) of ovarian, fallopian tube, or primary peritoneal cancer. Approved November 14, 2014.

•Ramucirumab (Cyramza), a recombinant monoclonal antibody, was approved for treatment (in combination with paclixatel) of advanced gastric or gastroesophageal junction adenocarcinoma. Approved November 5, 2014.

•Pembrolizumab (Keytruda), a PD-1–blocking antibody, was granted accelerated approval for the treatment of unresectable or metastatic melanoma. Accelerated approval granted September 4, 2014.

•Bevacizumab (Avastin), a vascular endothelial growth factor–­specific angiogenesis inhibitor, was approved for treatment (in combination with paclitaxel/cisplatin or paclitaxel/topotecan) of cervical cancer. ­Approved August 14, 2014.

•Idelalisib (Zydelig) tablets, a kinase inhibitor, was approved for the treatment of relapsed chronic lymphocytic leukemia. Approved July 23, 2014.

•Belinostat (Beleodaq), a histone deacetylase inhibitor, was granted accelerated approval for treatment of relapse or refractory peripheral T-cell lymphoma. Accelerated approval granted July 3, 2014.

•Ceritinib (Zykadia), a kinase inhibitor, was granted accelerated approval for treatment of anaplastic lymphoma kinase (ALK)-positive, non–small cell lung cancer. Accelerated approval granted April 29, 2014.

•Mercaptopurine (Purixan) oral suspension, a nucleoside metabolic inhibitor, was approved for treatment of acute lymphoblastic leukemia (ALL). Approved April 28, 2014.

•Siltuximab (Sylvant) injection, an interleukin-6 (IL-6) antagonist, was approved for treatment of multicentric Castleman’s disease. Approved April 23, 2014.

•Ofatumumab (Arzerra) injection, a CD20-directed cytolytic monoclonal antibody, was approved for treatment of chronic lymphocytic leukemia (CLL). Approved April 17, 2014.

•Ibrutinib (Imbruvica), a kinase inhibitor, was granted accelerated approval for treatment of chronic lymphocytic leukemia (CLL). Accelerated approval granted February 12, 2014.

•Trametinib (Mekinist) and ­dabrafenib (Tafinlar), two kinase inhibitors, were granted accelerated approval for use in combination, for treatment of unresectable or metastatic melanoma. Accelerated approval granted January 10, 2014. ■