Roche’s personalised medicine Zelboraf receives positive opinion from European authority

Roche today announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended that Zelboraf be granted full marketing authorization 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, M.D., chief medical officer and head, Global Product Development. “We are working closely with health authorities worldwide to bring Zelboraf to people with this deadly disease as soon as possible.”

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 diagnosis1). Earlier this year, Zelboraf became the first and only US 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.

The corresponding European Commission decision on the Marketing Authorization of Zelboraf is expected in February 2012.

Marketing authorization submissions for Zelboraf are currently under review by health authorities in Australia, New Zealand, Brazil, India, Mexico, Canada and other countries worldwide. While Roche seeks regulatory approval of Zelboraf in other countries, a global safety study is providing access to Zelboraf for people with previously treated or untreated BRAF V600 mutation-positive metastatic melanoma.