Cotellic (cobimetinib)

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Cotellic (cobimetinib)

How to buy Cotellic (cobimetinib): You can order Cotellic (cobimetinib) from TheSocialMedwork if the drug has not been approved or is not available in your country. We help patients and doctors get access to medicines at the lowest price worldwide.

Oncology Skin Cancer
Marketing Authorisation Holder Roche Registration GmbH
Mode of Action Kinase inhibitor (chemotherapy)
Administration Oral
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Strength 20 milligram
Package 63 Tablets

What is Cotellic (cobimetinib) for?

Cobimetinib is a cancer medicine used to treat adults with melanoma. Cotellic (cobimetinib) is indicated in combination with vemurafenib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. The presence of BRAF V600E or V600K mutation in tumour samples needs to be confirmed prior to initiation of treatment1,2,3.

How does Cotellic (cobimetinib) work?

The active substance in Cotellic, cobimetinib, is a kinase inhibitor. In melanoma with the BRAF V600 mutation, an abnormal form of the protein BRAF is produced, which switches on a protein (MEK), involved in stimulating normal cell division. This encourages the cancer to develop by allowing uncontrolled division of the cancer cells.

By blocking this protein cobimetinib slows down the growth and spread of the cancer. Cobimetinib is only given to patients whose melanoma is caused by the BRAF V600 mutation and must be used in combination with the BRAF inhibitor vemurafenib1. Vemurafenib is an anticancer medicine that has been widely approved (e.g. by FDA since 20115, EMA since 20126, and TGA since 20127.

Is Cotellic (cobimetinib) approved?

Cobimetinib was approved by:

  • FDA (USA) on November 10, 20158

  • EMA (EU) on November 20, 20151

  • TGA (AUS) on April 5, 20163

How is Cotellic (cobimetinib) taken?

  • 60 mg orally once daily for the first 21 days of each 28-day cycle until disease progression or unacceptable toxicity

  • Confirm the presence of BRAF V600E or V600K mutation in tumour sample prior to initiation of treatment

Complete information about cobimetinib dosage and administration can be found in the resources section.

Note: Consult your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Cotellic (cobimetinib)?

Common adverse reactions

The most common adverse reactions (≥20% of patients) listed in the prescribing information include:

  • diarrhea
  • photosensitivity reaction
  • nausea
  • pyrexia
  • vomiting. 

Serious adverse reactions

The serious adverse reactions (≥5% of patients) listed in the prescribing information include:

  • grade 3 or 4 abnormal blood counts
    • increased GGT
    • increased CPK
    • hypophosphatemia
    • increased ALT
    • lymphopenia
    • increased AST
    • increased alkaline phosphatase
    • hyponatremia.

Use in a specific population

Cotellic (cobimetinib) can be fatal for a fetus, it is advised to avoid pregnancies and breastfeeding.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information2,3,4.

More Information
Working ingredient cobimetinib
Shipping method Standard (not temperature controlled)
Package 63
Therapeutic Area Oncology
Oncology Skin Cancer
Indication Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation
Administration Oral
Mode of Action Kinase inhibitor (chemotherapy)
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Marketing Authorisation Holder Roche Registration GmbH

The approvals were based on a study (coBRIM) involving 495 patients with BRAF V600 positive unresectable locally advanced or metastatic melanoma. Participants received either vemurafenib plus placebo or vemurafenib plus cobimetinib. The evaluation was primarily based on the progression free survival (PFS). Secondary efficacy endpoints included overall survival (OS), objective response rate (ORR), and duration of response (DoR)3,2,4. The PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse9. The OS is the time from the start of the study to the death of the patient10. The ORR is the portion of patients with a tumour size reduction of a predefined amount for a minimum time period10. The DoR is the time from documentation of tumour response to disease progression11.

Patients taking cobimetinib plus vemurafenib (N = 247) resulted in a median PFS of 5 months longer than those taking vemurafenib plus placebo (N = 248) (12.3 months (95% CI 9.5, 13.4) vs. to 7.2 months (95% CI 5.6, 7.5) 4,2). The median OS in the cobimetinib cohort was 22.3 months (95% CI 20.3, Not Evaluable) vs 17.4 (CI 95% 15.0, 19.8)4,3. The ORR was 69.6% (95% CI 63.5%, 75.3%) with cobimetinib and 50.0% (95% CI 43.6%, 56.4%) 4,2 without. The median DoR was 13 months (95% CI 11.1, 16.6) 4,2 when cobimetinib was included in the treatment and 9.2 months (95% CI 7.5, 12.8)4,2 for patients that took vemurafenib plus placebo.

1. Human Medicines: Cotellic (cobimetinib), [PDF] EMA
    cited March 2013

2. Summary of Product Characteristics [FDA]: Cotellic (cobimetinib) [PDF]
    Genentech, Nov 2015.

3. Summary of Product Characteristics [TGA]: Cotellic (cobimetinib) [PDF]
    Roche Products Pty Ltd., April 2016.

4. Summary of Product Characteristics [EMA]: Cotellic (cobimetinib) [PDF]
    Roche Ltd., Nov 2015.

5. Vemurafenib
    cited March 2017
6. Human Medicines: Zelboraf (vemurafenib), EMA
    cited March 2017.

7. Summary of Product Characteristics [TGA]: Zelboraf (vemurafenib) [PDF]
    Roche Products Pty Ltd., Sep 2016.

8. FDA News Release: FDA approves Cotellic as part of combination treatment for advanced melanoma
    Nov 2015
9. NCI Dictionary of Cancer Terms: progression-free survival NIH National Cancer Institute`
    cited March 2017

10. Endpoints for assessing drug activity in clinical trials, The Oncologist
      Pazdur R. April 2008

11. Efficacy endpoints in oncology clinical trials, cited March 2017

Shipping Type Standard
Shipping method Standard (not temperature controlled)
This content has been reviewed by our medical doctor Jan de Witt.

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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. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.