About Targeted Therapies
cobimetinib (Cotellic) + vemurafenib (Zelboraf)
debrafenib (Tafinlar) + trametinib (Mekinist)
MONO TARGETED THERAPIES
vemurafenib (Zelboraf)
vemurafenib (Zelboraf)
Vemurafenib (Zelboraf) is a first line treatment for patients with BRAF V600 mutation-positive unresectable stage IIIC or IV melanoma or metastatic melanoma. About half of all melanoma skin cancers make too much BRAF due to a change in a gene. Vemurafenib slows down or stops the growth of cancer cells. The drug is administered as pills taken daily.
ZELBORAF targets proteins made from the mutated BRAF gene and slows down or stops the growth of cancer cells.
- for more information visit Roche Canada
Side Effects
Common side effects can include skin thickening, rash, itching, sensitivity to the sun, headache, fever, joint pain, fatigue, hair loss, and nausea. Less common but serious side effects can include heart rhythm problems, liver problems, kidney failure, severe allergic reactions, severe skin or eye problems, and increased blood sugar levels.
Some people treated with this drug develop new squamous cell skin cancers. These cancers are usually less serious than melanoma and can be treated by removing them. Still, your doctor will want to check your skin often during treatment and for several months afterward. You should also let your doctor know right away if you notice any new growths or abnormal areas on your skin.
Always talk to your doctor, pharmacist or nurse about your side effects so they can help you manage them.
Provincial Funding Summary
Vemurafenib (Zelboraf) for Advanced Melanoma (pCODR 10006)
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.
BC Funded
Funded, Oct 1, 2012
Unresectable stage III or stage IV melanoma; BRAF V600 mutation-positive; ECOG 0-2; 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
Unresectable stage III or stage IV melanoma; BRAF V600 mutation-positive; ECOG 0-2; 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
AB Funded
Funded, Oct 19, 2012
Criteria updated Oct. 30, 2018: For the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma alone or in combination with cobimetinib. Not to be used if progression on treatment with an alternate BRAF inhibitor and/or MEK inhibitor.
Criteria updated Oct. 30, 2018: For the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma alone or in combination with cobimetinib. Not to be used if progression on treatment with an alternate BRAF inhibitor and/or MEK inhibitor.
SK Funded
Funded, Sep 4, 2012
Melanoma – Advanced:
– Completion of the SCA Treatment Evaluation Program (STEP) request form for each patient is required for treatment approval,
– First line treatment of patients with BRAF V600 mutation-positive advanced melanoma (unresectable stage IIIC or metastatic) with a good performance status (ECOG 0 or 1),
– Interim eligibility as a second or subsequent line of therapy for patients with BRAF V600 mutation-positive advanced melanoma (unresectable stage IIIC or metastatic) with a good performance status (ECOG 0 or 1) who did not receive Vemurafenib in the first line setting.
Melanoma – Advanced:
– Completion of the SCA Treatment Evaluation Program (STEP) request form for each patient is required for treatment approval,
– First line treatment of patients with BRAF V600 mutation-positive advanced melanoma (unresectable stage IIIC or metastatic) with a good performance status (ECOG 0 or 1),
– Interim eligibility as a second or subsequent line of therapy for patients with BRAF V600 mutation-positive advanced melanoma (unresectable stage IIIC or metastatic) with a good performance status (ECOG 0 or 1) who did not receive Vemurafenib in the first line setting.
MB Funded
Funded, Sep 24, 2012
For the treatment of patients:
With unresectable or metastatic (Stage IIIC or IV) melanoma AND
With an Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less AND
With anticipated life expectancy of more than 3 months AND
Who have received at least one line of systemic therapy for advanced melanoma OR
With intolerance to a previous line of systemic therapy for advanced melanoma.
For the treatment of patients:
With unresectable or metastatic (Stage IIIC or IV) melanoma AND
With an Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less AND
With anticipated life expectancy of more than 3 months AND
Who have received at least one line of systemic therapy for advanced melanoma OR
With intolerance to a previous line of systemic therapy for advanced melanoma.
ON Funded
Funded, Aug 31, 2012
1st Line Setting Initial requests: As monotherapy for the first (1st) line treatment of patients with BRAF V600 mutation-positive unresectable stage IIIC or IV melanoma or metastatic disease. Recommended Dose: 960 mg twice daily until disease progression or development of unacceptable toxicity requiring discontinuation of vemurafenib. Patients should have their disease status assessed at least every 3 months.
Approval duration: 6 months
Renewal requests: Vemurafenib 960 mg orally twice daily may be continued until evidence of disease progression* or development of unacceptable toxicity requiring discontinuation of vemurafenib.
*Documentation from physician outlining the radiological and clinical benefit requiring continuation of the drug and verifiying that there has been no disease progression or development of unacceptable toxicity. Approval duration: 6 months
2nd Line Setting Initial requests: As monotherapy, for the second (2nd) line treatment of patients with BRAF V600 mutation-positive unresectable stage IIIC or IV melanoma or for patients with metastatic disease who have progressed after receiving treatment in the first line setting. Recommended Dose: 960 mg twice daily until disease progression or development of unacceptable toxicity requiring discontinuation of vemurafenib Patients should have their disease status assessed at least every 3 months.
Approval duration: 6 months
Renewal requests: Vemurafenib 960 mg orally twice daily may be continued until evidence of disease progression* or development of unacceptable toxicity requiring discontinuation of vemurafenib.
*Documentation from physician outlining the radiological and clinical benefit requiring continuation of the drug and verifiying that there has been no disease progression or development of unacceptable toxicity
Approval duration: 6 months Exclusion Criteria: BRAF V600 negative, or wild type tumors, or unknown mutation status will not be funded
1st Line Setting Initial requests: As monotherapy for the first (1st) line treatment of patients with BRAF V600 mutation-positive unresectable stage IIIC or IV melanoma or metastatic disease. Recommended Dose: 960 mg twice daily until disease progression or development of unacceptable toxicity requiring discontinuation of vemurafenib. Patients should have their disease status assessed at least every 3 months.
Approval duration: 6 months
Renewal requests: Vemurafenib 960 mg orally twice daily may be continued until evidence of disease progression* or development of unacceptable toxicity requiring discontinuation of vemurafenib.
*Documentation from physician outlining the radiological and clinical benefit requiring continuation of the drug and verifiying that there has been no disease progression or development of unacceptable toxicity. Approval duration: 6 months
2nd Line Setting Initial requests: As monotherapy, for the second (2nd) line treatment of patients with BRAF V600 mutation-positive unresectable stage IIIC or IV melanoma or for patients with metastatic disease who have progressed after receiving treatment in the first line setting. Recommended Dose: 960 mg twice daily until disease progression or development of unacceptable toxicity requiring discontinuation of vemurafenib Patients should have their disease status assessed at least every 3 months.
Approval duration: 6 months
Renewal requests: Vemurafenib 960 mg orally twice daily may be continued until evidence of disease progression* or development of unacceptable toxicity requiring discontinuation of vemurafenib.
*Documentation from physician outlining the radiological and clinical benefit requiring continuation of the drug and verifiying that there has been no disease progression or development of unacceptable toxicity
Approval duration: 6 months Exclusion Criteria: BRAF V600 negative, or wild type tumors, or unknown mutation status will not be funded
NS Funded
Funded, Mar 4, 2013
As a first line, single agent for the treatment of BRAF V600 mutation positive unresectable or metastatic melanoma in patients with an ECOG performance status (PS) of ≤ 1.
For BRAF V600 mutation positive patients who have progressed after first line treatment prior to vemurafenib availability, funding of vemurafenib as a second line agent may be considered.
As a first line, single agent for the treatment of BRAF V600 mutation positive unresectable or metastatic melanoma in patients with an ECOG performance status (PS) of ≤ 1.
For BRAF V600 mutation positive patients who have progressed after first line treatment prior to vemurafenib availability, funding of vemurafenib as a second line agent may be considered.
NB Funded
Funded, Sep 11, 2013
1) For the first line treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma who have an ECOG status performance of ≤1.
2) For the second line treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma who have an ECOG performance status of ≤1 and did not receive vemurafenib as first line treatment.
1) For the first line treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma who have an ECOG status performance of ≤1.
2) For the second line treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma who have an ECOG performance status of ≤1 and did not receive vemurafenib as first line treatment.
NL Funded
Funded, Dec 20, 2013
As a first-line therapy for patients presenting with BRAF V600 mutation-positive unresectable stage IIIC or IV melanoma or for patients who develop metastatic disease. Patients should have good performance status (ECOG ≤ 1), and, if brain metastases are present, the metastases must have been previously treated and be stable.
As a second-line therapy for patients with BRAF V600 mutation-positive unresectable stage IIIC or IV melanoma and good performance status (ECOG ≤ 1), who have progressed on first-line therapy before vemurafenib was available.
Approval Period: 6 months
Recommended Dose: 960 mg twice daily until disease progression or development of unacceptable toxicity requiring discontinuation of vemurafenib.
Renewals will be considered for patients who do not have evidence of disease progression AND who have not developed unacceptable toxicities that require discontinuation of vemurafenib.
As a first-line therapy for patients presenting with BRAF V600 mutation-positive unresectable stage IIIC or IV melanoma or for patients who develop metastatic disease. Patients should have good performance status (ECOG ≤ 1), and, if brain metastases are present, the metastases must have been previously treated and be stable.
As a second-line therapy for patients with BRAF V600 mutation-positive unresectable stage IIIC or IV melanoma and good performance status (ECOG ≤ 1), who have progressed on first-line therapy before vemurafenib was available.
Approval Period: 6 months
Recommended Dose: 960 mg twice daily until disease progression or development of unacceptable toxicity requiring discontinuation of vemurafenib.
Renewals will be considered for patients who do not have evidence of disease progression AND who have not developed unacceptable toxicities that require discontinuation of vemurafenib.
PEI Funded
Funded, Apr 27, 2015
As a first line, single agent for the treatment of BRAF V600 mutation positive unresectable or metastatic melanoma in patients with an ECOG performance status (PS) of 0 or 1. For BRAF V600 mutation positive patients who have progressed after first line treatment prior to vemurafenib availability, funding or vemurafenib as a second line agent may be considered. 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.
As a first line, single agent for the treatment of BRAF V600 mutation positive unresectable or metastatic melanoma in patients with an ECOG performance status (PS) of 0 or 1. For BRAF V600 mutation positive patients who have progressed after first line treatment prior to vemurafenib availability, funding or vemurafenib as a second line agent may be considered. 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.
HELPFUL RESOURCES
Melanoma What You Need To Know
A leading national melanoma resource written with the help of specialists in oncology and health care.
Watch Now Melanoma Updates and Treatments
Melanoma Support
The Melanoma Network of Canada has a number of free services for patients, caregivers and healthcare professionals.