Genentech submits new drug application for advanced melanoma combination treatment

Genentech has submitted a new drug application to the U.S. Food and Drug Administration for use of cobimetinib in combination with vemurafenib as treatment for BRAF V600 mutation-positive advanced melanoma, according to a press release.

Results of a phase 3 study, which demonstrated that patients with BRAF V600 mutation-positive advanced melanoma who received cobimetinib plus vemurafenib (Zelboraf, Genentech/Daiichi Sankyo) had significantly longer progression-free survival (PFS) compared with patients treated with vemurafenib alone, were used for the new drug application.

“We look forward to working with the FDA as they review the NDA and hope the combination of cobimetinib and Zelboraf will soon become a new option for people with BRAF mutation-positive advanced melanoma,” Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, said in the release.

The risk of disease worsening or death was reduced by half in the combination cobimetinib and vemurafenib treatment group. Patients treated with cobimetinib plus vemurafenib had a median PFS of 9.9 months, whereas patients treated with vemurafenib had a PFS of 6.2 months, according to the release.

Grade 3 or higher adverse events (AEs) included liver abnormalities, elevated creatine phosphokinase and diarrhea for cobimetinib plus vemurafenib. Nausea, rash, photosensitivity and lab abnormalities were other AEs reported for the combination treatment, according to the release.

Study results were presented at the European Society of Medical Oncology Annual Congress and published in the New England Journal of Medicine. Roche, of which Genentech is a member, has submitted the study data to the European Medicines Agency, according to the release.

Reference: www.gene.com.