Roche files for US and EU approval of vemurafenib for metastatic skin cancer

US biotech giant Genentech, part of Swiss drug major Roche (SIX: ROG), has submitted a New Drug Application for vemurafenib (RG7204, PLX4032) to the US Food and Drug Administration for people with BRAF V600 mutation-positive metastatic melanoma, and Roche filed a Marketing Authorization Application with the European Medicines Agency for the drug 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 product is the first personalized medicine to show a significant overall survival in metastatic melanoma, the company said.

Roche and Genentech are developing the compound under an up to $335 million 2009 accord with the USA’s Plexxikon, which last month was acquired for $805 million by Japanese drug major Daiichi Sankyo (The Pharma Letter March 1). Under the terms of the existing agreements, the Japanese firm will co-promote vemurafenib in the USA with Genentech.