cobimetinib (Cotellic) + vemurafenib (Zelboraf)

TARGET THERAPIES

About Targeted Therapies


cobimetinib (Cotellic) + vemurafenib (Zelboraf)


debrafenib (Tafinlar) + trametinib (Mekinist)

cobimetinib (Cotellic) + vemurafenib (Zelboraf)

COTELLIC is a prescription medicine that is used with the medicine ZELBORAF, to treat melanoma:

  • Vemurafenib blocks the activity of a mutated form of a molecule called BRAF. Cobimetinib blocks the activity of a molecule called MEK. BRAF and MEK are protein molecules that are important in regulating cell growth.The BRAF V600E and V600K mutations signal cells to grow abnormally and divide out of control. These cells can become a melanoma tumor. About half of all melanomas have a BRAF mutation. MEK receives signals from BRAF and other molecules in the cell. In melanoma treatment, researchers have found that blocking BRAF and MEK at the same time is more effective than blocking MEK alone.The combination of vemurafenib and cobimetinib interferes with abnormal BRAF signals to slow or stop the out-of-control cell growth:
    • Vemurafenib blocks the signaling pathway of the V600E-mutated BRAF molecule.
    • Cobimetinib blocks signaling from the V600E- or V600K-mutated BRAF molecule via the MEK molecule.
  • for more information visit Roche Canada

Side Effects

The most common side effects of COTELLIC in combination with ZELBORAF include:

  • diarrhea
  • nausea
  • fever
  • vomiting
  • sunburn or sun sensitivity

Always talk to your doctor, pharmacist or nurse about your side effects so they can help you manage them.

Provincial Funding Summary

Cobimetinib (Cotellic) for Metastatic Melanoma (pCODR 10070) Click Here to visit CADTH pan-Canadian Oncology Drug Review
This information is current as of November 9, 2018.
Note: Funding criteria as listed on the decision date. Please refer to the provincial drug programs for the most recent funding criteria and program eligibility.

Section
BC Funded
AB Funded
SK Funded
MB Funded
ON Funded
NS Under provincial consideration
NB Funded
NL Funded
PEI Funded
BC Funded

Funded, Sept 1, 2017
In combination with vemurafenib for Previously untreated BRAF V600 mutation-positive unresectable or metastatic melanoma stage III or IV:
• Good performance status
• Life expectancy of at least 3 months
• 18 years and older (for patients younger than 18 years old, CAP will review the eligibility on a case-by-case basis)
• Adequate hematological, hepatic and renal function
• If brain metastases are present, they must have been previously treated and be stable
• A BCCA “Compassionate Access Program” request with appropriate clinical information for each patient must be approved prior to treatment
Note: only one BRAF/MEK targeted treatment will be funded (daBRAFenib, trametinib, or combination)

AB Funded

Funded, Nov 28, 2017
Criteria updated Oct. 30, 2018: For the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation in combination with vemurafenib Not to be used if progression on treatment with alternative BRAF inhibitor and/or MEK inhibitor.

SK Funded

Funded, Sept 1, 2017
In combination with Vemurafenib, for the treatment of patients with previously untreated BRAF V600 mutation-positive unresectable stage Ill or stage IV melanoma who have a good performance status.

MB Funded

Funded, Oct 19, 2017
In combination with Zelboraf (vermurafenib), for the treatment of patients with previously untreated BRAF V600 mutation-positive unresectable stage III or stage IV melanoma who have a good performance status. Treatment should continue until unacceptable toxicity or disease progression. If brain metastases are present, patients should be asymptomatic or have stable symptoms.

ON Funded

Funded, Nov 17, 2017
Initial requests: For the treatment of patients with previously untreated BRAF V600 mutation-positive unresectable stage Ill or stage IV melanoma who have a good performance status (ECOG ≤ 2). As first-line combination therapy with vemurafenib; AND If brain metastases are present, they should be asymptomatic or stable Recommended Dose as combination dual therapy with Vemurafenib: Cobimetinib 60mg once daily for 21 days, followed by seven days off treatment; AND Vemurafenib 960mg twice daily for 28 days. Both drugs are given until disease progression or unacceptable toxicity. Renewal requests: Combination dual therapy may be continued until evidence of disease progression or development of unacceptable toxicity requiring discontinuation. Letter from physician outlining radiological and clinical benefit requiring continuation of the drug and verification of no disease progression or development of unacceptable toxicity must be submitted. Requests in patients who have initiated another BRAF and/or MEK inhibitor as monotherapy or combination therapy will be considered on a case-by-case basis ONLY IF there has been no disease progression.

NB Funded

Funded, Sept 22, 2017
For the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, when used as first line therapy, in combination with vemurafenib. Renewal criteria: Written confirmation that the patient has responded to treatment and there is no evidence of disease progression. Clinical Notes: 1. Patients must have a good performance status. 2. If brain metastases are present, patients should be asymptomatic or have stable symptoms. 3. Treatment should be discontinued upon disease progression or unacceptable toxicity. Claim Notes: Cobimetinib will not be reimbursed in patients who have progressed on BRAF targeted therapy. Initial approval duration: 6 months Renewal approval duration: 6 months.

NL Funded

Funded, Jun 1, 2017
In combination with vemurafenib, for the treatment of patients with previously untreated BRAF V600 mutation-positive unresectable stage III or stage IV melanoma who have a good performance status. Treatment should continue until unacceptable toxicity or disease progression. If brain metastases are present, patients should be asymptomatic or have stable symptoms.

PEI Funded

Funded, Aug 1, 2018
In combination with vemurafenib, for the treatment of patients with previously untreated BRAF V600 mutation-positive unresectable stage III or stage IV melanoma who have a good performance status. Treatment should continue until unacceptable toxicity or disease progression. If brain metastases are present, patients should be asymptomatic or have stable symptoms. Approvals are for a maximum daily dose of 60mg during 21 consecutive days per 28 day cycle. The request for coverage must be made and the medication prescribed by a specialist in haematology or medical oncology, or a general practitioner acting under the direction of those specialists.

Please note: This information is not meant to act as a treatment decision aid, but rather to provide general information about which metastatic melanoma or skin cancer treatments are covered by provincial health care plans in Canada. It is current to the date indicated and may not be currently accurate due to the changing landscape of coverage in Canada. If you have private insurance coverage, you may have access to therapies not covered by the provincial plans in your province.  All information obtained about specific treatments should be further discussed with your physician.

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