The FDA granted regular approval to lorlatinib (Lorbrena, Pfizer) for metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
The FDA also approved the Ventana ALK (D5F3) CDx assay (Ventana Medical Systems) as a companion diagnostic for lorlatinib.
Data from the pivotal phase 3 CROWN trial, on which the approval was based, show that lorlatinib “can significantly improve outcomes in the first-line treatment of ALK-positive non-small cell lung cancer,