The US Food and Drug Administration has granted a priority review for Roche’s cobimetinib in combination with the company’s already-marketed melanoma drug Zelboraf.

Specifically, the agency will look at cobimetinib, a MEK inhibitor developed with Exelixis, in combination with Zelboraf (vemurafenib), for people with BRAF V600 mutation-positive advanced melanoma. The combo was filed at the end of last year based on the coBRIM Phase III study, which showed that it improved progression-free survival compared to Zelboraf alone (9.9 versus 6.2 months).

Having a priority review means the FDA will take six months to assess the submission rather than the standard 10 months. The agency will make a decision on approval by August 11.

For more details, go to: http://www.pharmatimes.com/Article/15-02-19/Roche_gets_priority_review_for_melanoma_drug_cobimetinib.aspx