US FDA thumbs up for Exelixis/Genentech's new targeted combo melanoma regimen

The US Food and Drug Administration today approved Cotellic (cobimetinib) to be used in combination with vemurafenib (trade name Zelboraf) to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K mutation).

The approval means that people who have advanced (metastatic) melanoma and test positive for the most common genetic mutation in melanoma, BRAF V600, will now have a new option available to help stop their cancer from progressing.

Swiss oncology giant Roche (ROG: SIX) subsidiary Genentech’s vemurafenib was approved in 2011 as a stand-alone treatment for BRAF V600E mutant melanoma that cannot be removed by surgery. Cobimetinib, a MEK inhibitor, is being developed through a collaboration between Genentech and US drugmaker Exelixis(Nasdaq: EXEL). Data showed that patients treated with the combination experienced a median of 12.25 months with no tumor progression, compared to 7.2 months for patients on vemurafenib alone.