Swiss approval for Cotellic (cobimetinib) + Zelboraf (vemurafenib) to treat advanced melanoma- Roche

Exelixis announced that Swissmedic, the medical licensing and supervisory authority of Switzerland, 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 member of the Roche Group. The trade name for cobimetinib in Switzerland is Cotellic.

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. Genentech filed its New Drug Application (NDA) for cobimetinib with the FDA in December 2014 and the Prescription Drug User Fee Act date is November 11, 2015. Separately, Roche filed a Marketing Authorization Application with the European Medicines Agency in late 2014, and Roche anticipates a regulatory decision before the end of 2015.

Comment: The combination of MEK and BRAF inhibition may change the standard of care in advanced melanoma as it provides a more complete blockade of the MAP kinase pathway which should delay the emergence of resistance.