Exelixis/Roche gets first regulatory approval of cobimetinib, in Switzerland

US drugmaker Exelixis (Nasdaq: EXEL) says that Swissmedic, the Swiss licensing and supervisory body, has approved cobimetinib for use in combination with vemurafenib as a treatment for patients with advanced melanoma.

Cobimetinib is a selective inhibitor of MEK that was discovered by Exelixis and is the subject of a worldwide collaboration agreement between Exelixis and Genentech, a subsidiary of Swiss pharma giant Roche (ROG: SIX). The trade name for cobimetinib in Switzerland is Cotellic. Exelixis’ shares rose more than 8% to $5.64 ahead of the announcement.

Roche’s Swiss regulatory submission for cobimetinib was based on data from coBRIM, the Phase III pivotal trial of cobimetinib and vemurafenib conducted in 495 patients with previously untreated unresectable, locally advanced or metastatic melanoma with a BRAF V600 mutation. The resulting approval is the first for cobimetinib worldwide, and additional regulatory applications are under review in other territories.