Roche receives CHMP backing for combination melanoma therapy

Roche has received a recommendation from the Committee for Medicinal Products for Human Use (CHMP) for EU approval of a new combination melanoma therapy.

The European Medicines Agency committee has a positive opinion for Cotellic in combination with Zelboraf for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma.

Data from the pivotal phase III coBRIM study showed that people who received the combination therapy lived more than a year without their disease worsening, with the objective response rate being higher compared to Zelboraf alone.

Additionally, data 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.

Dr Sandra Horning, chief medical officer and global head of product development at Roche, said: "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."

This comes after the firm's Perjeta/Herceptin combination therapy was approved in Europe for the treatment of early-stage aggressive breast cancer in July.