Regulatory Guidance

Roche, Exelixis Seek FDA Approval on Melanoma Combo

Dec 16, 2014

Exelixis and collaborator Genentech, a member of the Roche Group, have filed a New Drug Application (NDA) with the FDA for a combination melanoma treatment.

The combination features cobimetinib, a specific MEK inhibitor discovered by Exelixis, and Roche's Zelboraf, already on the market.

According to FierceBiotech, in a Phase III study disclosed over the summer, the combination treatment helped subjects live significantly longer without tumor growth than those treated with Zelboraf alone. Patients treated with the combination reported a median progression-free survival of 9.9 months compared to 6.2 months on Zelboraf, the companies reported.

Read the press release