Roche, Daiichi expect early FDA approval for Melanoma Drug Vemurafenib

Information gathered from close sources reveal that the US regulatory agency might approve an oral BRAF inhibitor vemurafenib jointly developed by Roche and its partner Daiichi Sankyo for treating certain patients with metastatic melanoma, no later than this week. While Roche filed for drug clearance May, the FDA was expected to pass a judgment on the application by November.

Although the source stated, “we are getting the sense that approval is imminent,” an FDA representative said that the November deadline is “a performance goal post” for the agency, and refrained from commenting further on the timing of a decision.

The companies were also seeking US FDA approval in parallel for a companion diagnostic capable of detecting BRAF mutation, with the same anticipated decision time as the drug approval. The test will also be registered in Europe.
The drug proposed to be marketed under the brand name Zelboraf, if approved, is expected to make annual sales reaching $732 million by 2015, as predicted by analysts.