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United States. Food and Drug Administration

Genentech's Cobimetinib Receives Priority Review from FDA for Advanced Melanoma Treatment

Strategic Insights

— 1 min read

Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company's New Drug Application (NDA) for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma. This decision comes after the FDA evaluated the results of the coBRIM Phase III study, which demonstrated that the combination of cobimetinib and Zelboraf reduced the risk of disease worsening or death by half in patients with the condition. The FDA will make a decision on approval by August 11, 2015.

Key Takeaways:

  • The FDA has granted Priority Review status to Genentech's New Drug Application (NDA) for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma.
  • The NDA is based on results of the coBRIM Phase III study, which showed that the combination of cobimetinib and Zelboraf reduced the risk of disease worsening or death by half in patients with BRAF V600 mutation-positive advanced melanoma.
  • Common adverse events observed at a higher frequency in the combination arm compared to the Zelboraf arm included diarrhea, nausea, photosensitivity, lab value abnormalities, and vomiting.
  • Other select adverse events that were lower in the combination arm included cutaneous squamous cell carcinomas and keratoacanthomas.
  • Cobimetinib is designed to selectively block the activity of MEK, a protein inside cells that makes up a signaling pathway that helps regulate cell division and survival.
  • Cobimetinib binds to MEK while Zelboraf binds to mutant BRAF, another protein on the pathway, to interrupt abnormal signaling that can cause tumors to grow.

Statistics:

  • The coBRIM Phase III study demonstrated that the combination of cobimetinib and Zelboraf reduced the risk of disease worsening or death by 50% (hazard ratio [HR]=0.51, 95 percent confidence interval [CI] 0.39-0.68; p-value not provided).
  • In the combination arm, 65% of patients experienced a higher overall frequency of Grade 3 or higher adverse events compared to 59% in the Zelboraf arm.
  • 57% of patients in the combination arm experienced diarrhea compared to 28% in the Zelboraf arm.

Sources:

  • Biotechnology Companies, "Genentech Announces FDA Priority Review for Cobimetinib in Combination with Zelboraf for BRAF V600 Mutation-Positive Advanced Melanoma," (2015)
  • FDA, "FDA Approves Zelboraf for Melanoma," (2011)
  • Genentech, "Zelboraf (vemurafenib) for the Treatment of Melanoma," (2015)
  • Exelixis, "Cobimetinib (GDC-0973, XL518) Fact Sheet," (2015)

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