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FDA grants priority review to cobimetinib combined with Zelboraf for advanced melanoma
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The FDA today has granted priority review to cobimetinib in combination with vemurafenib for the treatment of patients with BRAF V600-positive advanced melanoma, according to a press release from the drug’s manufacturer.
“We are pleased the FDA has accepted our application for cobimetinib in combination with Zelboraf and granted it priority review status,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a press release. “We look forward to working with the FDA to bring this new treatment option to people with BRAF mutation-positive advanced melanoma as soon as possible.”
The FDA based its decision on results of the coBRIM phase 3 study, which showed that cobimetinib (Genentech) with vemurafenib (Zelboraf, Genentech) reduced the risk of disease worsening or death by half in patients who received the combination (HR = 0.51; 95% CI, 0.39-0.68).
Median PFS was 9.9 months for cobimetinib plus vemurafenib compared with 6.2 months with vemurafenib alone.
Patients in the combination arm experienced a higher overall frequency of grade 3 or higher adverse events (65% vs. 59%).
The most common grade 3 or higher adverse events in the combination arm included liver lab value abnormalities, elevated creatine phosphokinase and diarrhea.
Common adverse events were higher in the combination arm compared with patients who received vemurafenib alone. The most common adverse events in the combination arm included diarrhea (57% vs. 28%), nausea (39% vs. 24%), photosensitivity (28% vs. 16%) and lab value abnormalities (24% vs. 18%).
The FDA will make its decision on approval by Aug. 11.