The FDA approved 34 new molecular entities in its fiscal year ending September 30, 2011; the highest number since 2007. Eleven biologics license applications were approved. Biologic approvals included a high number of orphan indicators and first-time approvals for companies. Seattle Genetics’ Adcetris for treating Hodgkin’s lymphoma and systemic anaplastic large cell lymphoma was approved. It is the only antibody conjugate on the market. Human Genome Sciences and GlaxoSmithKline’s Benlysta gained approval, making it the first drug for lupus to be approved since 1955. The approval of Jakafi was the first approval of a Janus-associated kinase inhibitor and the first approval for Incyte, which developed the drug with Novartis. For the second year in a row, the FDA approved a cancer immunotherapy, giving the nod to Bristol-Meyers Squibb’s Yervoy for melanoma. Two companion diagnostics were approved: Genentech’s Zelboraf, which was approved in combination with a multiplex PCR–based diagnostic test for the BRAF V600E gene, and Pfizer’s Xalkori, which requires a fluorescent in situ hybridization test for the anaplastic lymphoma kinase gene.

Source: Nature Biotechnology