Roche receives CHMP recommendation for Zelboraf

Roche has been granted a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for its personalised cancer drug Zelboraf.

The European Medicines Agency committee has recommended that the drug be granted full marketing authorisation as a monotherapy for adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

It comes after the drug, which is designed for use in conjunction with Roche's cobas 4800 BRAF V600 Mutation Test, has already become the first and only personalised treatment for this specification in the US and Switzerland.

The European Commission is expected to give its final decision on the marketing authorisation of Zelboraf in February 2012.

Dr Hal Barron, Roche's chief medical officer and head of global product development, said: "The CHMP recommendation to approve Zelboraf represents an important milestone for people with metastatic melanoma who until recently had limited treatment options."

This comes after the company received CE Mark approval earlier this month for its cobas EGFR Mutation Test, for use in testing patients for compatibility with Tarceva treatment.