Alunbrig

Brigatinib

• Brand(s): Alunbrig
• Dosage Form/Strength: 30 mg, 90 mg, 180 mg tablet; 7x90 mg and 21x180 mg oral starter kit
• Effective date: February 10, 2022

Initial Criteria

For the treatment of anaplastic lymphoma kinase (“ALK”) – positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) in patients meeting ALL the following criteria:

1. 18 years of age or older; AND

2. Patient has not been treated with another ALK inhibitor for NSCLC; AND

3. Brigatinib is used as monotherapy; AND

4. Patient has good performance status.

Exclusion criteria:

• Brigatinib will not be funded in patients who have experienced disease progression on an ALK inhibitor.
• Brigatinib will not be funded as combination therapy with another ALK-inhibitor.

Notes:

1. Patients who have received chemotherapy or radiation therapy should wait 2 weeks before starting brigatinib.
2. On a time-limited basis, patients who have developed intolerances to crizotinib or alectinib used within a first line setting, and who meet the above criteria, may be considered for a switch to brigatinib on a case-by-case basis. Provide details of the intolerances including the grade of toxicity (as applicable) and reasons for the switch.

Renewal Criteria:
Ongoing funding will be considered in patients who have not experienced disease progression or unacceptable toxicities to treatment with brigatinib.

Recommended dose: Starting dose of 90 mg daily for the first 7 days and, if tolerated, dose increased to 180 mg daily.

Approval duration of initial and renewal requests: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests