dabrafenib (Tafinlar) + trametinib (Mekinist)

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Dabrafenib (Tafinlar) + trametinib (Mekinist)

Dabrafenib (Tafinlar) capsules and trametinib (Mekinist) tablets are prescription medicines that can be used in combination to treat melanoma:

That has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable), and
That has a certain type of abnormal “BRAF” (V600E or V600K mutation-positive) gene

Dabrafenib (Tafinlar) capsules and trametinib (Mekinist) can be used in combination to help prevent melanoma that has a certain type of abnormal “BRAF” gene from coming back after the cancer has been removed by surgery. Dabrafenib acts as an inhibitor of the BRAF protein and slows down or stops the growth of cancer cells while trametinib acts against the MEK protein. Both BRAF and MEK are key molecules that help regulate cell growth. A BRAF mutation signals cells, via MEK, to develop abnormally and divide out of control and grow into a melanoma tumour.

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Side Effects

The most common side effects include: headaches, anemia, changes in eyesight, diarrhea, swelling, and fatigue. Rare but serious side effects can include heart damage, excess bleeding, loss of vision, lung problems, and skin infections.

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

Provincial Funding Summary

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Dabrafenib (Tafinlar) in combination with Trametinib (Mekinist) for Metastatic Melanoma (pCODR 10053)
This information is current as of June 13, 2019

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

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Funded, Aug 1, 2016
BRAF V600 mutation-positive unresectable or metastatic melanoma.
• Previously untreated or as second line treatment for patients previously treated with first line pembrolizumab or ipilimumab or nivolumab or combination.
• Only one BRAF/MEK targeted treatment will be funded (daBRAFenib, trametinib, or combination).
• ECOG 0 to 1.
• Adequate hematological, hepatic and renal function.
• If brain metastases are present, patients should be asymptomatic or stable.

Funded, Oct 18, 2016
Criteria update Oct. 30, 2018: Dabrafenib and/or trametinib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation. Not to be used after progression on an alternate BRAF inhibitor and/or MEK inhibitor.

Funded, Aug 8, 2016
First line BRAF targeted therapy (i.e. patients may be treatment naïve or previously treated with checkpoint inhibitor immunotherapy and/or chemotherapy) with the combination of Dabrafenib and Trametinib in patients with BRAF V600 mutation positive unresectable or metastatic melanoma who have an ECOG performance status of 0 or 1 and stable brain metastases (if present).

Funded, Jul 21, 2016
For the treatment of Unresectable or Metastatic Melanoma when used in combination with Tafinlar (dabrafenib).

Funded, Aug 10, 2016
Initial requests: As a first line treatment of BRAF V600 mutation-positive, unresectable or metastatic melanoma; OR as a second line treatment of BRAF V600 mutation-positive, unresectable or metastatic melanoma in which the disease has progressed after receiving treatment in the first line setting. If brain metastases are present, they should be asymptomatic or stable. Exclusion criteria: BRAF V600 negative, or wild type tumours, or unknown status will not be funded. o Dabrafenib-trametinib combination therapy will not be considered for funding in patients who have progressed on a prior BRAF inhibitor therapy.

Funded, Sept 1, 2016
Tafinlar Mekinist combination therapy as a first-line BRAF-mutation targeted treatment for patients with BRAF V600 mutation positive, unresectable or metastatic melanoma and who have an ECOG performance status of 0 or 1. Treatment should continue until disease progression. If brain metastases are present, patients should be asymptomatic or have stable symptoms.

Funded, Mar 13, 2017
For the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, when used as first line therapy, alone or in combination with trametinib.

Funded, Feb 1, 2017
First-line BRAF-mutation targeted treatment (i.e. patients may be treatment naïve or previously treated with checkpoint inhibitor immunotherapy and/or chemotherapy) with Tafinlar Mekinist (Dabrafenib Trametinib) combination therapy for patients with BRAF V600 mutation positive, unresectable or metastatic melanoma and who have an ECOG performance status of 0 or 1. If brain metastases are present, patients should be asymptomatic or have stable symptoms. Treatment should continue until disease progression.

Funded, Oct 29, 2018

Melanoma – Advanced (Unresctable or Metastatic)
-For the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma when used alone or in combination with trametinib. Clinical
Notes: 1. Patients must have an ECOG performance status of 0 or 1. 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. Patients must apply for coverage under the High-Cost Drug Program. If written by an oncologist, this medication does not require the submission of a Pharmacare Special Authorization form.

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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