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Cotellic Approval History

  • FDA approved: Yes (First approved November 10th, 2015)
  • Brand name: Cotellic
  • Generic name: cobimetinib
  • Dosage form: Tablets
  • Company: Genentech, Inc.
  • Treatment for: Melanoma, Metastatic

Cotellic (cobimetinib) is a kinase inhibitor indicated for use in combination with vemurafenib for the treatment of advanced melanoma with a BRAF V600E or V600K mutation.

FDA Approval: The safety and efficacy of Cotellic taken in combination with vemurafenib were based on results from the Phase III coBRIM study of 495 patients with previously untreated, BRAF V600 mutation-positive advanced melanoma. All study participants received vemurafenib and were then randomly selected to also take either Cotellic or a placebo. On average, patients taking Cotellic plus vemurafenib experienced a delay in the amount of time it took for their disease to worsen (approximately 12.3 months after starting treatment) compared to the patients taking vemurafenib only (approximately 7.2 months after starting treatment). The patients taking Cotellic plus vemurafenib also lived longer and experienced complete or partial shrinkage of their tumors.

Mechanism: BRAF and MEK are proteins in a cell signaling pathway that help control cell growth and survival. Vemurafenib is designed to inhibit some mutated forms of BRAF, and Cotellic is designed to inhibit some forms of MEK. When used in combination, Cotellic and vemurafenib are thought to reduce cancer cell growth longer than with vemurafenib alone.

Administration: Cotellic is an oral tablet usually taken once daily for 21 days followed by a 7-day rest period (no drug) for a 28-day cycle. Doses can be taken with or without food.

Side Effects: The most common side effects of treatment with Cotellic in combination with vemurafenib are diarrhea, sensitivity to sunlight, nausea, fever and vomiting.

Additional Information: Cotellic may cause severe side effects including cardiomyopathy, rhabdomyolysis, new skin cancers, retinal detachment, severe skin rash, hepatotoxicity, hemorrhage and severe photosensitivity reactions. Patients should avoid sun exposure and protect themselves against sunburn. Women taking Cotellic should use effective contraception, as the medication can cause harm to a developing fetus.

Development History and FDA Approval Process for Cotellic

DateArticle
Nov 10, 2015Approval FDA Approves Cotellic (cobimetinib) for the Combination Treatment of Advanced Melanoma
Jul  1, 2015Exelixis Provides Update on Genentech’s Pending NDA for Cobimetinib
Feb 18, 2015FDA Grants Genentech's Cobimetinib Priority Review for Use in Combination with Zelboraf in Advanced Melanoma
Dec 14, 2014Genentech Submits NDA to FDA for Investigational Cobimetinib Used in Combination with Zelboraf (vemurafenib) in Advanced Melanoma

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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