Lorbrena

Lorlatinib

• Brand(s): Lorbrena
• Dosage Form/Strength: 25mg, 200 mg tablets
• Effective date: July 17, 2023

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 prior systemic treatment for advanced or metastatic NSCLC; AND

3. Lorlatinib is used as monotherapy; AND

4. Patient has good performance status.

Exclusion criteria:

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

Notes:

1. Patients who have received chemotherapy or radiation therapy before confirmation of ALK status, may switch to lorlatinib once ALK positivity is confirmed.

2. Lorlatinib should not be used in patients with severe acute or chronic medical or psychiatric conditions.

3. On a time-limited basis, patients who have developed intolerances to crizotinib, alectinib, or brigatinib used within a first line setting, and who otherwise meet the above criteria, may be considered for a switch to lorlatinib 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 lorlatinib.

Recommended dose: 100 mg once daily

Approval duration of initial and renewal requests: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests