Genentech submits vemurafenib NDA for BRAF V600 mutation-positive metastatic melanoma

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company submitted a New Drug Application for vemurafenib (RG7204, PLX4032) to the U.S. Food and Drug Administration (FDA) for people with BRAF V600 mutation-positive metastatic melanoma, and that Roche submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for vemurafenib in the same indication. 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 regulatory submissions of vemurafenib and the companion diagnostic to identify people with the type of melanoma specifically targeted by this medicine are exciting steps toward our goal of delivering a personalized therapy for this disease.”

"We have worked swiftly to advance the vemurafenib development program knowing that patients with metastatic melanoma have a poor prognosis and limited options," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "The regulatory submissions of vemurafenib and the companion diagnostic to identify people with the type of melanoma specifically targeted by this medicine are exciting steps toward our goal of delivering a personalized therapy for this disease."

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 melanoma, as determined by the investigational companion diagnostic test also being developed by Roche. Roche submitted a Premarket Approval Application (PMA) for the cobas 4800 BRAF V600 Mutation Test in the U.S. The test will also be registered in Europe.