FDA approves Cotellic

FDA granted marketing approval to Cotellic cobimetinib to treat malignant melanoma patients with V600E or V600K BRAF mutations in combination with Zelboraf vemurafenib. The Genentech unit of Roche (SIX:ROG; OTCQX:RHHBY) has worldwide rights to Cotellic from Exelixis Inc. (NASDAQ:EXEL), which in 2013 exercised its option to co-promote the MEK inhibitor in the U.S.

Genentech said it plans to launch the drug in the U.S. within two weeks. Spokesperson Holli Kolkey told BioCentury the monthly cost of Cotellic will be about $6,600. The company said it will offer assistance programs for qualified patients. ...