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Cotellic (cobimetinib)

Cotellic® (cobimetinib) is used to treat certain kinds of advanced melanoma. Cotellic is taken in combination with a drug called Zelboraf® (vemurafenib).1 Cotellic treats melanoma with BRAF V600E or V600K mutation. Your doctor will test for BRAF mutation. Cotellic is not used for melanoma with a normal BRAF gene.

Cotellic is used when the melanoma:1

  • Cannot be removed with surgery (unresectable) or
  • Has spread to distant parts of the body (metastasized)

Cotellic does not come in generic form. Cotellic is similar to Mekinist® (trametinib), another drug approved to treat unresectable or metastatic melanoma.

How does Cotellic work?

Cotellic is a type of medication called a kinase inhibitor. It works by blocking a protein called MEK that passes along signals for cell growth.

MEK is a protein in a pathway called MAPK (also called ERK). This pathway involves a chain of events that allow cells to grow and survive. Normally, there are mechanisms that turn each protein “on” and “off.” These mechanisms keep cell processes under control. However, between 10% and 50% of melanomas have mutations in the gene (instructions) for a protein called BRAF.2 These mutations cause BRAF to stay “on,” sending continuous signals resulting in uncontrolled cell growth.3

MEK comes after BRAF in this chain of events. Cotellic blocks MEK from working and stops the signal from continuing. Cotellic is called a targeted therapy because it targets one feature that makes cancer cells different from normal cells.

Zelboraf is a BRAF inhibitor. When Zelboraf and Cotellic are used together, they target the MAPK pathway at two points. This combination stops or slows the growth of melanomas with BRAF mutations better for some people than either drug alone.1

How effective is Cotellic?

Cotellic was studied in combination with Zelboraf. All of the patients in the pivotal trial had metastatic or unresectable melanoma with BRAF V600 mutations. Compared with Zelboraf alone, combination therapy resulted in:1

  • Greater response to treatment
  • Fewer deaths
  • Longer overall survival
  • Fewer people with cancer progression
  • Longer time until cancer progression

In this trial, 70% of people treated with Cotellic plus Zelboraf had a response to treatment, compared with 50% of people treated with Zelboraf alone. The median progression-free survival was 12.3 months and 7.2 months, respectively, for combination and Zelboraf alone. Progression-free survival is how long a person survives after treatment without the cancer getting worse. Median overall survival was 22.3 months with combination therapy and 17.4 months with Zelboraf alone.4

How do I take Cotellic?

Before taking Cotellic, read the Medication Guide that comes in the package. Follow your doctor’s instructions for taking Cotellic.

Cotellic comes as tablets that are taken by mouth. Cotellic is taken in 28-day cycles. You will take Cotellic once per day for 21 days, followed by 7 days off treatment. You can take Cotellic with or without food.

Patients should take their medication as prescribed by their doctor. Patients should talk to their doctor if they have any questions, or if they have questions regarding their cobimetinib regimen.

You will continue cycles of Cotellic until the cancer progresses or the side effects are unacceptable.1

What are the side effects of Cotellic?

You are at risk of new cancers while taking Cotellic.1 This medication has been linked to other types of skin cancer such as squamous cell carcinoma, keratoacanthoma, and basal cell carcinoma. Possible signs of new cancers include: new wart, skin sore, reddish bump, or mole that changes in size or color.

The most common side effects of Cotellic include:1

  • Nausea and vomiting
  • Fever
  • Diarrhea
  • Sun sensitivity (photosensitivity)

Less common but serious side effects of Cotellic include:1

  • Bleeding problems
  • Heart problems
  • Severe skin reaction
  • Eye problems
  • Liver problems
  • Muscle problems (also called rhabdomyolysis)

This is not a complete list of adverse effects.

Who should not take Cotellic?

Pregnant women should not take Cotellic.1 Women who could become pregnant should use birth control during treatment. Continue using birth control for at least 2 weeks after the last dose of Cotellic. Do not breastfeed while taking Cotellic. Do not breastfeed for 2 weeks after your last dose of Cotellic.

Tell your doctor about any medical conditions you have, especially:

  • Current or past skin problems
  • Bleeding problems
  • Heart problems
  • Eye problems
  • Liver problems
  • Muscle problems

What precautions are needed when taking Cotellic?

You will need regular skin exams while taking Cotellic.1 Your doctor will do a skin exam before you start this medication. You will need skin exams every 2 months while taking this medication and for up to 6 months afterward. Your doctor will also look for non-skin cancers.

Try to avoid sunlight while taking Cotellic.1 This medication makes your skin sensitive to sunlight and you may burn more easily. If you are outside, wear a wide-brimmed hat and long clothing. Use sunscreen and lip balm with a sun protection factor (SPF) of 30 or more.

During treatment and for at least 2 weeks after the last dose of Cotellic:1

  • Women who can become pregnant should use birth control.
  • Women should not breastfeed.
Written by: Sarah O'Brien | Last reviewed: June 2019.
  1. Cotellic® [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; November 2015.
  2. Lovly C, Pao W, Sosman J. 2016. Molecular profiling of melanoma. My Cancer Genome (Updated January 26).
  3. Lo JA, Fisher DE. The melanoma revolution: from UV carcinogenesis to a new era in therapeutics. Science. 2014;346:945-949.
  4. Ascierto PA, McArthur GA, Dréno B, et al. Cobimetinib combined with vemurafenib in advanced BRAF(V600)-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial. Lancet Oncol. 2016;17:1248-1260.