BRIEF—FDA approves lorlatinib for metastatic ALK-positive NSCLC

The US Food and Drug Administration granted regular approval to lorlatinib for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, detected by an FDA-approved test.

The drug is marketed by US pharma giant Pfizer’s under the brand name Lorbrena.

The FDA also approved the Ventana ALK (D5F3) CDx Assay (from Ventana Medical Systems) as a companion diagnostic for lorlatinib.

Lorlatinib received accelerated approval in November 2018 for the second- or third-line treatment of ALK-positive metastatic NSCLC.

This current approval is based on data from Study B7461006 (NCT03052608), which demonstrated an improvement in progression-free survival (PFS) as assessed by blinded independent central review (BICR), with a hazard ratio of 0.28 (95% CI: 0.19, 0.41; p<0.0001).

Median PFS was not estimable in the lorlatinib arm and was 9.3 months (95% CI: 7.6, 11.1) for those treated with crizotinib. Overall survival data were immature at the PFS analysis.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence.

For this review, FDA collaborated with the Australian Therapeutic Goods Administration (TGA), the Brazilian Health Regulatory Agency (ANVISA), Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The application reviews are ongoing at the other agencies.