CHMP recommends Cotellic and Zelboraf combo in advanced melanoma

The CHMP has adopted a positive opinion for Roche’s Cotellic (cobimetinib), when used in combination with Zelboraf (vemurafenib), for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma.

Approximately 50% of melanoma skin cancers are BRAF-positive, and more than 55,000 people worldwide die every year from melanoma.

“Today’s CHMP positive opinion is a substantial step forward for people with BRAF-positive skin cancer in Europe and around the world,” said Sandra Horning, M.D., Chief Medical Officer and Global Head of Product Development. “The Cotellic and Zelboraf combination will provide physicians with a powerful therapeutic option that can help patients live significantly longer without their disease progressing compared to Zelboraf alone.” 

FDA expected to make a decision on Cotellic and Zelboraf by the end of the year

The CHMP’s recommendation is based primarily on results of the pivotal Phase III coBRIM study. These data showed that people who received the combination of Cotellic and Zelboraf lived over a year without their disease worsening. The objective response rate was also higher for the combination arm compared to Zelboraf alone.

Supportive data early in development from the Phase Ib BRIM7 study indicated that the combination of Cotellic and Zelboraf helped people who had not been previously treated with a BRAF inhibitor live more than two years (median overall survival 28.5 months).

Based on this CHMP recommendation, a final decision regarding the approval of the combination of Cotellic and Zelboraf is expected from the European Commission by the end of 2015. 

Cotellic recently received approval in Switzerland for use in combination with Zelboraf as a treatment for patients with advanced melanoma, and the US. Food and Drug Administration (FDA) is expected to make a decision on Roche’s new drug application for the combination before the end of the year.