On March 3, 2021, the Food and Drug Administration granted regular approval to lorlatinib (Lorbrena, Pfizer Inc.) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ALK-positive, detected by an FDA-approved test, Ventana ALK (D5F3) CDx Assay (Ventana Medical Systems, Inc.).
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), a randomized, multicenter, open-label, active-controlled trial conducted in 296 patients with ALK-positive metastatic NSCLC who had not received prior systemic therapy for metastatic disease.
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fda.gov/drugs/drug-approvals-and-databases/fda-approves-lorlatinib-metastatic-alk-positive-nsclc