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United States. Food and Drug Administration

Genentech Announces FDA Priority Review for Cobimetinib in Combination with Zelboraf

Strategic Insights

— 2 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 for the treatment of people with BRAF V600 mutation-positive advanced melanoma. The FDA will make a decision on approval by August 11, 2015.

The Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention, or diagnosis of a disease. 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 who received the combination.

Key Takeaways:

  • Cobimetinib in combination with Zelboraf has been granted Priority Review by the FDA for the treatment of people with BRAF V600 mutation-positive advanced melanoma.
  • The combination reduced the risk of disease worsening or death by half in patients who received the treatment.
  • The coBRIM Phase III study includes 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma.
  • The study showed a higher overall frequency of Grade 3 or higher adverse events in the combination arm compared to the Zelboraf arm, with close to half of these due to lab value abnormalities.
  • Common adverse events observed at a higher frequency in the combination arm included diarrhea, nausea, photosensitivity, and vomiting.
  • The FDA will make a decision on approval by August 11, 2015.
  • The combination has the potential to provide significant improvements in the treatment of people with BRAF V600 mutation-positive advanced melanoma.

statistics:

  • 495 patients were enrolled in the coBRIM Phase III study.
  • The study showed a hazard ratio (HR) of 0.51, 95 percent confidence interval (CI) of 0.39-0.68, and a p-value of less than 0.0001, indicating a significant reduction in the risk of disease worsening or death.
  • The combination of cobimetinib and Zelboraf was associated with a higher overall frequency of Grade 3 or higher adverse events, with 65 percent in the combination arm compared to 59 percent in the Zelboraf arm.

Sources:

  • Genentech news release: "Genentech Announces FDA Acceptance and Priority Review of New Drug Application for Cobimetinib in Combination with Zelboraf for the Treatment of BRAF V600 Mutation-Positive Advanced Melanoma" (no date).
  • Roche website: "Zelboraf (vemurafenib) - Important Safety Information" (no date).
  • American Cancer Society website: "Melanoma: What's New in Melanoma Research?" (no date).
  • Exelixis website: "About Cobimetinib (GDC-0973, XL518)" (no date).
  • Daiichi Sankyo Group website: "Plexxikon - About" (no date).
  • Genentech website: "About Genentech" (no date).

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