Roche Submits New Drug Application for Vemurafenib
Roche has submitted a New Drug Application for vemurafenib to the FDA and a Marketing Authorization Application to the EMA for approval for people with BRAF V600 mutation-positive metastatic melanoma.
Roche announced that the company submitted a New Drug Application for vemurafenib (RG7204, PLX4032) to the U.S. FDA and a Marketing Authorization Application to the EMA for approval for people with BRAF V600 mutation-positive metastatic melanoma.
Roche also submitted an application for the cobas 4800 BRAF V600 Mutation Test, a companion diagnostic. Vemurafenib, a "BRAF-inhibitor", is designed to selectively target and inhibit a mutated form of the BRAF protein found in about half of all cases of melanoma, the deadliest and most aggressive form of skin cancer.
The submissions are based on results from two positive clinical studies (BRIM2 and BRIM3) that evaluated vemurafenib in people with BRAF V600 mutation-positive metastatic me
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