Tafinlar

Dabrafenib

• Brand(s): Tafinlar
• Dosage Form/Strength: 50 mg, 75 mg capsule
• Updated January 7, 2020

Initial Criteria:

For the mutation-targeted treatment of patients with BRAF V600 mutation-positive unresectable melanoma or metastatic melanoma meeting the following criteria:

1. As monotherapy or as combination therapy with trametinib;

2. If brain metastases are present, they should be asymptomatic or stable

Exclusion Criteria:

• BRAF V600 negative, or wild type tumors, or unknown status will not be funded
• Funding will not be considered in patients who have experienced progression on a BRAF mutation targeted therapy. The Ministry will fund only one BRAF mutation targeted treatment/treatment regimen.
• May be sequenced after immunotherapies or other funded treatments, however, treatment beyond third line will not be considered for funding.

Recommended Dose as Monotherapy:
150 mg twice daily until disease progression or development of unacceptable toxicity requiring discontinuation of dabrafenib

Recommended Dose as combination dual therapy with Trametinib:
Dabrabenib 150 mg twice daily and Trametinib 2mg once daily until disease progression or development of unacceptable toxicity requiring discontinuation

Renewal Criteria:
Therapy as monotherapy OR as combination dual therapy (as above) may be continued until evidence of disease progression¹ or development of unacceptable toxicity requiring discontinuation.

¹Letter from physician outlining radiological and clinical benefit requiring continuation of the drug and verification of no disease progression must be submitted.

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

Case by case:
Requests in patients who have initiated another single-agent BRAF or MEK inhibitor therapy will be considered on a case-by-case basis ONLY IF there has been no disease progression.

For the adjuvant treatment of resected Stage III cutaneous melanoma in patients meeting ALL the following criteria:

1. Dabrafenib is being used as combination therapy with Trametinib

2. Patient’s cutaneous melanoma met the following requirements prior to resection:
   a) Histologically confirmed stage IIIA (limited to lymph node metastases of > 1 mm), IIIB, IIIC, or IIID cutaneous melanoma [8th edition of the American Joint Committee on Cancer staging system]
   b) BRAF V600 mutated (all BRAF V600 mutations)

3. Post-resection, clinical or radiographic confirmation of complete disease resection including absence of in-transit metastases must be provided.¹

4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2

¹Micrometastatic lymph node involvement detected by sentinel lymph node biopsy will be allowed.

Exclusion Criteria:

• Patients with stage IIIA cutaneous melanoma with lymph node metastases less than 1 mm.
• Monotherapy with Dabrafenib
• Combinations with other anticancer therapies

Recommended Dose in adjuvant therapy:
Dabrabenib 150 mg twice daily and Trametinib 2mg once daily

Notes: Treatment administered post-resection until disease recurrence or unacceptable toxicity to a maximum of 12 months of treatment in total. (Note: 12 months refers to duration of adjuvant treatment accessed through all sources of funding (i.e., private and public).

Approval duration: Maximum of 12 months. Renewals are not considered.

Additional notes:

1. The Ministry will reimburse for provincially funded treatments for use in the adjuvant setting in patients with cutaneous melanoma for a total duration of up to 12 months. Overall access to adjuvant therapy will be limited to 12 months in total and combines the duration of use of all treatments administered in the adjuvant setting.
2. Funding will not be granted for dabrafenif-trametinib in patients who have used another treatment in the adjuvant setting for cutaneous melanoma for a duration of 3 months or longer.
3. A one-time switch to dabrafenif-trametinib in the adjuvant cutaneous melanoma setting will be permitted for BRAF-mutated patients who switch from another adjuvant treatment that has been used for less than 3 months and upon meeting the above funding criteria.
4. Patients who experience disease progression within 6 months of completion of adjuvant BRAF therapy will not be funded for another BRAF targeted therapy.
5. Switching to cobimetinib-vemurafenib from dabrafenib-trametinib will not be permitted in BRAF-positive patients.

EAP Drug Request Form:

Standard Form for EAP Drug Requests