Roche’s Zelboraf approved for skin cancer in Europe

Roche has received approval from the European Commission for its drug Zelboraf to be marketed as a treatment for a fatal form of skin cancer.

The treatment has been ratified as a monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, following on from its US approval last year.

Zelboraf is a personalised therapy option targeted at those who test positive for BRAF V600 mutations using the Roche cobas 4800 BRAF V600 Mutation Test, and is the only treatment to show efficacy among both previously untreated and previously treated patients.

Dr Hal Barron, chief medical officer and head of global product development at Roche, said: "Zelboraf significantly improves patient survival and exemplifies the benefits that Roche's personalised approach to medicine can provide for patients, physicians and society."

Last week, the UK's National Institute for Health and Clinical Excellence asked Roche to provide it with additional data on its lung cancer drug Tarceva, in order to help the regulator decide whether or not to approve it for NHS use.