FDA uses national‑priority voucher — Boehringer gets first‑line lung label

The FDA expanded the label for Boehringer Ingelheim’s oral drug Hernexeos to include first‑line treatment of HER2‑positive non‑small cell lung cancer under a pilot program that accelerates review of products with national interest. The approval adds an oral option in an indication with limited first‑line therapies. Regulatory coverage noted the decision used an expedited pathway to speed patient access. The label change is likely to shift treatment algorithms for HER2‑positive lung cancer and underscores the FDA’s willingness to deploy priority mechanisms for select oncology indications.