Genentech, which is a member of the Roche Group, announced the submission of a New Drug Application (NDA) for cobimetinib to the U.S. Food and Drug Administration (FDA) to be used in combination with Zelboraf® (vemurafenib) for people with BRAF V600 mutation-positive advanced melanoma.
The submission is based on the outcome of the coBRIM Phase III study, which showed those who revelaed the MEK inhibitor cobimetinib alongside Zelboraf had longer life spans and more time spent without their disease worsening when compared with those who did not take the drug, a press release stated.
"In the past several years we have made significant progress in treating advanced melanoma, but it remains a serious and difficult to treat cancer that affects more people each year," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "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."
In the study, 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma were instructed to take a 28-day cycle or more of Zelboraf along with either cobimetinib or a placebo on days one and 21. The treatment cycle was continued until the disease progressed, the patients showed unacceptable toxicity or withdrew from the trial.
The researchers found the combination of cobimetinib and Zelboraf cut the risk of the disease worsening or death in half, with an average progression-free survival (PFS) of 9.9 months compared to 6.2 months in those who took Zelboraf alone.
Common adverse side effects of cobimetinib included nausea, diarrhea, photosensitivity and lab abnormalities. Other less-frequent effects included arm hair loss, thickening of the outer layer of skin and joint pain.
The results were presented at the European Society of Medical Oncology (ESMO) 2014 Congress and published in the New England Journal of Medicine. Roche submitted the coBRIM data to the European Medicines Agency.
