The Pink Sheet reports that Roche/Genentech is seeking a broad label in metastatic melanoma for the just-filed oral BRAF inhibitor vemurafenib (formerly PLX4032) and priority review, which could possibly enable a U.S. launch at the end of 2011.
It's geared as a treatment for the roughly half of metastatic melanoma patients who test positive for the BRAF V600 mutation. A companion diagnostic to test for the mutation has been developed by Roche Molecular Systems, and has also been submitted for approval.
As a personalized therapy for the tough-to-treat disease, the drug has been widely described as a game-changer in melanoma.