The approval was based on data the Phase III coBRIM study, which demonstrated that Cotellic plus Zelboraf helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live for more than a year without worsening their disease.
Roche evaluated the safety and efficacy of 60 mg once daily of cobimetinib and 960 mg twice daily of Zelboraf compared to 960 mg twice daily of Zelboraf alone.
The objective response rate with the combination was 70%, compared to 50% in the Zelboraf arm.
Roche chief medical officer and head of global product development Sandra Horning said: "There has been significant progress in the treatment of melanoma, with more medicines being approved in the past five years than in the previous 30.
"Together, Cotellic plus Zelboraf more strongly suppressed cancer growth than Zelboraf alone. This underscores the critical role of combination medicines in helping melanoma patients live longer without their disease worsening."
Cotellic, which was discovered by Exelixis, is also being evaluated in combination with various investigational medicines, including an immunotherapy, in several tumour types like non-small cell lung cancer and colorectal cancer.
Roche is developing Cotellic in collaboration with Exelixis, a genomics-based drug discovery firm located in South San Francisco, California, US.