FDA Approves Cobimetinib with Vemurafenib for Advanced Melanoma

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The FDA has approved cobimetinib (Cotellic) for treatment of unresectable or metastatic melanoma in combination with vemurafenib (Zelboraf).
The FDA has approved cobimetinib (Cotellic) for treatment of unresectable or metastatic melanoma in combination with vemurafenib (Zelboraf).

The U.S. Food and Drug Administration (FDA) has approved cobimetinib (Cotellic) for the treatment of patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with vemurafenib (Zelboraf).1

“When used in combination, Cotellic and Zelboraf help delay disease progression and help people live significantly longer than with Zelboraf alone,” said Sandra Horning, MD, chief medical officer and head of Global Product Development of Roche and Genentech. “With this approval, people with this type of deadly and aggressive skin cancer now have a new targeted option.”2

The approval is based on results from the phase 3 coBRIM study, which demonstrated a 5.1-month improvement in median progression-free survival with cobimetinib plus vemurafenib compared with vemurafenib alone (HR, 0.56; 95% CI, 0.45 - 0.70; P < .001) in 495 patients with previously untreated BRAF V600 mutation-positive unresectable or metastatic melanoma.

An interim analysis also showed an improvement in overall survival with the combination (HR, 0.63; 95% CI: 0.47 - 0.85; P = .0019) and the objective response rate was 20% higher with 2 drugs than vemurafenib alone (P < .001).

In regard to safety, the most common adverse events associated with cobimetinib in combination with vemurafenib include diarrhea, sensitivity to ultraviolet light, nausea, pyrexia, and vomiting.1

Cobimetinib may also cause cardiomyopathy, rhabdomyolysis, primary cutaneous malignancies, retinal detachment, severe rash, hepatotoxicity, hemorrhage, and severe rash due to photosensitivity.

Clinicians should advise their patients to avoid sun exposure, wear protective clothing, and use a broad spectrum ultraviolet A/ultraviolet B sunscreen while taking cobimetinib. Women taking the MEK inhibitor should also be advised to use effective contraception during treatment.

RELATED: Intermittent vs Standard High-dose Interferon Alfa-2b for Stage 3 Melanoma

“Today's approval provides a new targeted treatment that, when added to vemurafenib, demonstrates greater benefit than vemurafenib alone in patients with BRAF mutation-positive melanoma,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.2


  1. FDA approves Cotellic as part of combination treatment for advanced melanoma [news release]. November 10, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncPressA/ucm471934.htm. Accessed November 10, 2015.
  2. FDA Approves Genentech's Cotellic™ (Cobimetinib) in Combination With Zelboraf® (Vemurafenib) in Advanced Melanoma [news release]. November 10, 2015. http://www.gene.com/media/press-releases/14611/2015-11-10/fda-approves-genentechs-cotellic-cobimet. Accessed November 10, 2015.

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