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.
Vemurafenib is also known by its brand name Zelboraf.

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.

Vemurafenib (Zelboraf) for Advanced Melanoma

Information from www.pcodr.ca

This information is current as of November 7, 2016
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. Oct 19, 2012 – FUNDED

Funding Criteria
Treatment of BRAF V600 mutation – positive resectable or metastatic melanoma or if patient is intolerant to dabrafenib and/or trametinib. Not to be used after progression on dabrafenib and/or trametinib. (updated October 18, 2016).Funded – Oct 1, 2012

Funding Criteria
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. Funded – Sep 24, 2012

Funding Criteria
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.

Funded – Sept. 11, 2013

Funding Criteria

  • 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.

Funded – December, 20, 2017

Funding Criteria

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. Funded – March, 4, 2013

Funding Criteria

  • 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.

Funded – Aug. 31, 2012

Funding Criteria

For the first line treatment of patients with BRAF V600 mutation-positive unresectable stage IIIC or IV melanoma or metastatic melanoma in patients meeting the following criteria:

    • Vemurafenib is being used as monotherapy;
    • AND Patients should have good performance status (ECOG ≤1);
  • AND If brain metastases are present, the patient must have been previously treated and must be stable.

For the second (2nd) line treatment of patients with BRAF V600 mutation-positive unresectable stage IIIC or IV melanoma OR for patients with metastatic melanoma who have progressed after receiving treatment in the first line setting in patients who meet the following criteria:

    • Vemurafenib is being used as monotherapy; AND
    • Patients should have good performance status (ECOG ≤1); AND
  • If brain metastases are present, they must have been previously treated and be stable*.

Patients meeting the following exclusion criteria will not be funded:

    • ECOG ≥ 2
  • BRAF V600 negative, or wild type tumors, or unknown status.

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.

*Definition of Stable – No metastases to the central nervous system (unless successfully treated for 3 months or more as demonstrated by no progression and with no requirement for corticosteroids).

**Please note that renewals must be accompanied by a letter from the physician outlining radiological and clinical benefit from treatment that supports that the drug should be continued AND this must include verification that the disease has not progressed while on vemurafenib. Funded – April 27, 2015

Funding Criteria

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. Funded – Sept. 4, 2012

Funding Criteria

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.

 

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.

Refrence: https://www.cancer.org/cancer/melanoma-skin-cancer/treating/targeted-therapy.html

PROPER USE OF THIS MEDICATION

Vemurafenib comes as tablets. You swallow them whole with a glass of water.
It is very important that you take tablets according to the instructions your doctor or pharmacist gives you.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    – Fax toll-free to 1-866-678-6789, or
    – Mail to: Canada Vigilance Program
    Health Canada
    Postal Locator 0701D
    Ottawa, Ontario
    K1A 0K9
    Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.