Newly Approved Drugs

The Food and Drug Administration (FDA) had a busy year in 2012, with 11 new hematology-oncology drug approvals. Additional approvals for new indications added to the list. Of note is that the majority of new oncology drugs are oral agents. The complete list of all 2012 FDA drug approvals (cardiology, infectious disease, etc.) can be found at the FDA’s Center Watch website.

The 2012 hematology-oncology drug approvals or new indications include:

Abraxane (paclitaxel protein-bound particles for injectable suspension); Celgene; For the treatment of non-small cell lung cancer, Approved October 2012

Afinitor (everolimus); Novartis; for the treatment of hormone receptor-positive, HER2-negative breast cancer, Approved July 2012

Bosulif (bosutinib); Pfizer; for the treatment of Ph+ chronic myelogenous leukemia, Approved September 2012

Cometriq (cabozantinib); Exelixis; for the treatment of metastatic medullary thyroid cancer, Approved November 2012

Erivedge (vismodegib); Genentech; for the treatment of basal cell carcinoma, Approved January 2012

Iclusig (ponatinib); Ariad Pharmaceuticals; for the treatment of chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia, Approved December 2012

Inlyta (axitinib); Pfizer; for the treatment of advanced renal cell carcinoma, Approved January 2012

Kyprolis (carfilzomib); Onyx Pharmaceuticals; for the treatment of multiple myeloma, Approved July 2012

Marqibo (vinCRIStine sulfate LIPOSOME injection); Talon Therapeutics; for the treatment of Ph- acute lymphoblastic leukemia, Approved August 2012

Neutroval (tbo-filgrastim); Teva Pharmaceuticals; for the reduction in the duration of severe chemotherapy-induced neutropenia, Approved August 2012

Omontys (peginesatide); Affymax; for the treatment of anemia due to chronic kidney disease, Approved March 2012

Perjeta (pertuzumab); Genentech; for the first-line treatment of HER2+ metastatic breast cancer, Approved June 2012

Stivarga (regorafenib); Bayer HealthCare Pharmaceuticals; for the treatment of previously treated patients with metastatic colorectal cancer, Approved September 2012

Synribo (omacetaxine mepesuccinate); Teva Pharmaceuticals; for the treatment of chronic or accelerated phase chronic myeloid leukemia, Approved October 2012

Votrient (pazopanib); GlaxoSmithKline; for the treatment of soft tissue sarcoma, Approved April 2012

Xtandi (enzalutamide); Medivation; for the treatment of metastatic castration-resistant prostate cancer, Approved August 2012

Zaltrap (ziv-aflibercept); Sanofi Aventis US; for the treatment of metastatic colorectal cancer, Approved August 2012