FDA Grants Accelerated Approval to Lorlatinib for ALK+ NSCLC

The FDA has granted lorlatinib (Lorbrena) an accelerated approval for the treatment of patients with ALK-positive metastatic non—small cell lung cancer (NSCLC) who have progressed on 1 or more ALK tyrosine kinase inhibitors (TKIs).

Specifically, lorlatinib is approved for patients who have progressed on crizotinib (Xalkori) and at least 1 other ALK inhibitor for metastatic disease; alectinib (Alecensa) as the first ALK inhibitor therapy for metastatic disease; or ceritinib (Zykadia) as the first ALK inhibitor therapy for metastatic disease.

The approval is based on a nonrandomized, dose-ranging, multicohort, multicenter phase II study (B7461001) that included a subgroup of 215 patients with ALK-positive metastatic NSCLC previously treated with ≥1 ALK kinase inhibitors. The overall response rate with lorlatinib in these 215 patients was 48% (95% CI, 42-55), including a complete response rate of 4% and a partial response rate of 44%. The median duration of response was 12.5 months (95% CI, 8.4-23.7).

The FDA-recommended dose of lorlatinib is 100 mg orally once daily.

Read the full article at OncLive.com.