Mektovi

Binimetinib

• Brand(s): Mektovi
• Dosage Form/Strength: 15 mg Tablet
• Effective date: December 6, 2022

Initiation Criteria

For the mutation-targeted treatment of BRAF V600 mutation-positive locally advanced, unresectable melanoma or metastatic melanoma in patients who meet ALL the following criteria:

1. Binimetinib will be used in combination with encorafenib; AND

2. Has histologically confirmed BRAF V600 mutation positive locally advanced unresectable or metastatic cutaneous melanoma or unknown primary melanoma (stage IIIB, IIIC, or IV per AJCC); AND

3. Has not received a previous treatment (i.e., treatment naïve) for locally advanced or metastatic disease OR has progressed on a prior first line immunotherapy for locally advanced or metastatic disease; AND

4. Good performance status; AND

5. Has adequate organ, bone marrow and cardiac function; AND

6. Prescribed by a clinician with expertise in the diagnosis and management of melanoma.

Notes:

1. Binimetinib and encorafenib may be considered in patients who have previously received a BRAF inhibitor (BRAFi)/MEK inhibitor (MEKi) in the adjuvant setting if disease relapse occurs more than 6 months after completion of adjuvant BRAFi/MEKi treatment.
2. The Ministry will fund only one BRAF mutation targeted treatment/treatment regimen for locally advanced or metastatic melanoma.
3. If brain metastases are present, they should be treated or asymptomatic and stable.
4. For a time-limited period, requests in patients who have initiated another BRAFi or MEKi treatment regimen will be considered for a switch to encorafenib/bimetinib on a case-by-case basis upon having met the above initiation criteria at the time of BRAFi/MEKi initiation and ONLY IF there has been no disease progression.
5. Patients should be assessed for a response (as per RECIST 1.1) to treatment with encorafenib and binimetinib every 2 to 3 months.
6. Treatment should be discontinued in those who develop adverse reactions that do not resolve despite dose delays or dose reductions

Exclusion Criteria

• Uveal or mucosal melanoma are not funded.
• BRAF V600 negative, or wild type tumors, or unknown status will not be funded
• Patients who have experienced disease progression on a BRAF targeted regimen for locally advanced or metastatic melanoma
• Binimetinib monotherapy will not be funded.

Renewal requests:

Renewal of binimetinib in combination with encorafenib may be continued until evidence of disease progression or development of unacceptable toxicity requiring discontinuation.

A letter from the prescriber confirming no clinical or radiological disease progression by RECIST 1.1 should be included.

Recommended dose:
Binimetinib 45 mg twice daily in combination with Encorafenib 450 mg once daily

Approval duration (both initial and renewal requests):
6 months (patients should have their disease status assessed at least every 6 months)

EAP Drug Request Form:

Standard Form for EAP Drug Requests