Positive opinion on personalised skin cancer medicine
Basel - It is a further push for Roche's ambitions in medicine concerning the treatment of skin cancer: The European Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug Zelboraf and its companion diagnostic test should be granted full marketing authorisation as a monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. “The CHMP recommendation to approve Zelboraf represents an important milestone for people with metastatic melanoma who until recently had limited treatment options,” said Hal Barron, chief medical officer and head of Global Product Development at Roche. Metastatic melanoma is the deadliest and most aggressive form of skin cancer with less than one in four people expected to be alive 12 months after their diagnosis. Earlier this year, Zelboraf became the first and only FDA and Swissmedic approved personalised medicine for people with BRAF V600 mutation-positive inoperable or metastatic melanoma that is shown to improve survival. The cobas 4800 BRAF V600 Mutation Test, co-developed by Roche, was approved simultaneously with Zelboraf in the US and CE-marked in the EU where it is commercially available. Zelboraf is designed to target and inhibit mutated forms of the BRAF protein found in about half of all cases of melanoma. Roche expects the corresponding European Commission decision on the Marketing Authorization of Zelboraf in February 2012.