FDA Approves Alecensa as Adjuvant Treatment for ALK-Positive NSCLC

The FDA approved alectinib (Alecensa, Genentech) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.

Efficacy was demonstrated in a global, randomized, open-label trial (ALINA; ClinicalTrials.gov Identifier: NCT03456076) in patients with ALK-positive NSCLC who had complete tumor resection. Eligible patients were required to have resectable stage IB (tumors ≥4 cm) to