FDA approves Genentech's Alecensa for early NSCLC

The US Food and Drug Administration (FDA) has approved the first and only ALK inhibitor for people with ALK-positive early-stage NSCLC (eNSCLC).

Developed by Swiss pharma giant Roche’s (ROG; SIX) subsidiary Genentech, Alecensa (alectinib) has been authorized for adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) - tumors ≥ 4 cm or node positive - as detected by an FDA-approved test.

Genentech said it plans to file for a similar label expansion with the European Medicines Agency. Alecensa is already approved in over 100 countries as an initial (first-line) and second-line treatment for ALK-positive, metastatic NSCLC, including in the USA, Europe, Japan and China. For full-year 2023, Alecensa generated sales of 1,502 million Swiss francs ($1.65 billion).