European approval for Roche skin cancer drug Zelboraf

Swiss drug major Roche (ROG: SIX) says that the European Commission has approved Zelboraf (vemurafenib) as a monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, the most aggressive form of skin cancer. Zelboraf is designed to target and inhibit mutated forms of the BRAF protein found in about half of all cases of melanoma.

“Today’s approval is important news for people with BRAF mutation-positive metastatic melanoma as Zelboraf significantly improves patient survival and exemplifies the benefits that Roche’s personalized approach to medicine can provide for patients, physicians and society,” said Hal Barron, chief medical officer and head, Global Product Development.

Zelboraf, as well as a companion diagnostic, was approved by the US Food and Drug Administration last summer (The Pharma Letter August 18, 2011), becoming the first and only FDA approved personalized medicine that is shown to improve survival for people with BRAF V600 mutation-positive unresectable or metastatic melanoma. Initial sales since its launch in the USA in August last year have been encouraging, said Roche along with reporting 2011 financial results (TPL February 1).