FDA Approves New Treatment Option for Advanced Melanoma

November 10th, 2015

On November 10, 2015, the FDA approved Cotellic (cobimetinib) for the treatment of people with BRAF V600E or V600K mutation-positive advanced melanoma, for use in combination with Zelboraf (vemurafenib). Cotellic and Zelboraf are not used to treat melanoma with a normal BRAF gene.

News in brief

• The pivotal coBRIM study showed Cotellic plus Zelboraf reduced the risk of disease worsening or death (progression-free survival; PFS) by about half and helped people live significantly longer (overall survival; OS) compared to Zelboraf alone
• This FDA approval underscores the important role of targeted medicines to help people with BRAF V600 mutation-positive advanced melanoma

Supporting Information

Important Safety Information

• Avoid sunlight during treatment with COTELLIC. COTELLIC can make your skin sensitive to sunlight. You may burn more easily and get severe sunburns. When you go outside, wear clothes that protect your skin, including your head, face, hands, arms, and legs. Use lip balm and a broad-spectrum sunscreen with SPF 30 or higher.
• COTELLIC may cause serious side effects, including risk of new skin cancers, bleeding problems, heart problems, severe rash, eye problems, liver problems, muscle problems (rhabdomyolysis), and skin sensitivity to sunlight (photosensitivity).
• Tell your doctor if you are pregnant or plan to become pregnant, as COTELLIC can harm your unborn baby. Females who are able to become pregnant should use effective birth control (contraception) during treatment with COTELLIC and for 2 weeks after the final dose of COTELLIC.
• Do not breastfeed during treatment and for 2 weeks after the final dose of COTELLIC. Talk to your healthcare provider about the best way to feed your baby during this time.
• Tell your healthcare provider about all the medicines you take. Some types of medicines will affect the blood levels of COTELLIC.
• Common side effects of COTELLIC in adults with unresectable or metastatic melanoma include diarrhea, sunburn or sun sensitivity, nausea, fever, and vomiting.
• Common side effects of COTELLIC in adults with histiocytic neoplasms include acne-like (red and pus filled) bumps of face, scalp, chest, or upper back, diarrhea, infections, tiredness, nausea, swelling of arms, legs, or feet, dry skin, rash with both flat and raised reddened area on your skin, itching, indigestion or heartburn, vomiting, urinary tract infection, and lung problems.
• COTELLIC can also cause changes in blood test results.

COTELLIC may cause fertility problems in males and females, which may affect your ability to have a child. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of COTELLIC.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see Full COTELLIC Prescribing Information and Patient Information for additional Important Safety Information.