FDA approves new targeted therapies for lung cancer

The U.S. Food and Drug Administration approved a subcutaneous formulation of amivantamab combined with lazertinib as a first‑line treatment for locally advanced or metastatic non‑small cell lung cancer (NSCLC) with common EGFR mutations. The regimen showed a 46% reduction in the risk of disease progression compared with osimertinib monotherapy and represents the first chemio‑free bispecific antibody‑based option for this patient group.

In a separate decision, the FDA also approved zidesamtinib for adults with locally advanced or metastatic ROS1‑positive NSCLC who have previously received a ROS1 inhibitor. In the pivotal ARROS‑1 trial, 44% of patients responded and 69% maintained disease control at 12 months, with activity against resistance mutations and brain metastases. Both approvals expand targeted treatment options for distinct molecular subtypes of lung cancer.