According to a source close to the matter, the FDA may approve Roche
and partner Daiichi Sankyo’s oral BRAF inhibitor vemurafenib for the
treatment of certain patients with metastatic melanoma as early as this
week. Roche filed for clearance of the drug in May, and the agency was scheduled to reach a decision on the application by November.
However, the source noted that “we are getting the sense that
approval is imminent.” An FDA spokeswoman declined to comment on the
timing of a decision, but said that the November deadline is “a
performance goal post” for the agency.
The companies had simultaneously filed for US approval of a
companion diagnostic to detect the BRAF mutation, with a decision
expected at the same time as the drug approval. The test will also be
registered in Europe.
Analysts have forecast that if approved, annual sales of the drug,
which is being proposed under the brand name Zelboraf, could reach $732
million by 2015.
