Alecensa: FDA-Approved First ALK Inhibitor for Adjuvant Treatment in Early-Stage ALK-Positive NSCLC

Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has approved Alecensa® (alectinib) as the first and only ALK inhibitor for adjuvant treatment of people with ALK-positive early-stage non-small cell lung cancer (NSCLC) who have undergone surgery. This approval is based on the Phase III ALINA study, which demonstrated that Alecensa reduced the risk of disease recurrence or death by 76% compared to chemotherapy. The National Comprehensive Cancer Network (NCCN) recommends routine testing for ALK, EGFR, and PD-L1 biomarkers in early-stage NSCLC to inform adjuvant therapy selection. Alecensa is already approved for first- and second-line treatment for metastatic ALK-positive NSCLC and has shown significant efficacy in patients, including those with central nervous system (CNS) metastases. The approval aims to address an urgent unmet need, as about half of early-stage NSCLC patients experience disease recurrence despite adjuvant chemotherapy.