One month after reporting enhanced overall survival (OS) in a pivotal study and one day before its PDUFA date, Genentech Inc.'s cobimetinib, branded Cotellic, was approved by the FDA for use in combination with Roche AG's Zelboraf (vemurafenib) to treat locally advanced or metastatic melanoma carrying a BRAF V600E or V600K mutation – subtypes that account for roughly half of the population of patients with melanoma.