Shares in Exelixis are on the rise after the firm received its first global regulatory approval for melanoma treatment cobimetinib in Switzerland.
SwissMedic has cleared use of the drug, which will be marketed in the country as Cotellic, in combination with Roche’s Zelboraf (vemurafenib) as a treatment for patients with advanced melanoma.
The Roche/Genentech-partnered drug is a selective inhibitor of MEK. The Swiss nod came on the back of an analysis of clinical trial data showing that patients with previously untreated BRAF V600 mutation-positive advanced melanoma live a median of more than a year (12.3 months) without disease progression on the combination therapy versus 7.2 months on Zelboraf monotherapy.
Also, patients responded better to treatment with cobimetinib and Zelboraf than those given the latter alone, with objective response rates of 70% and 50%, respectively.
Cobimetinib is also under review in Europe and the US. Genentech filed a New Drug Application with the US Food and Drug Administration in December 2014 and is expecting news on this by November 11. Separately, Roche filed a Marketing Authorisation Application with European regulators in late 2014, and is expecting a decision by the end of the year.