Genentech seeks regulatory approval for vemurafenib

SOUTH SAN FRANCISCO, Calif. — Genentech is seeking approval for a new drug to treat skin cancer, the company said Wednesday.

Genentech, part of Swiss drug maker Roche, announced that it had submitted a regulatory approval application to the Food and Drug Administration for RG7204 (vemurafenib), a treatment for BRAF V600 mutation-positive melanoma that has spread to other parts of the body, also known as metastasis. Melanoma is the deadliest and most aggressive form of skin cancer. The drug is designed to inhibit a mutated form of the BRAF protein found in about half of melanoma cases.

“We have worked swiftly to advance the vemurafenib development program, knowing that patients with metastatic melanoma have a poor prognosis and limited options,” Genentech chief medical officer and head of global product development Hal Barron said. “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.”