Skip to main content

Cotellic FDA Approval History

FDA Approved: Yes (First approved November 10, 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 Timeline for Cotellic

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.