FDA voucher speeds Boehringer label expansion for HER2 lung cancer

The FDA used a National Priority Voucher to accelerate review and approve Boehringer Ingelheim’s oral drug Hernexeos as a first‑line treatment for HER2‑positive non‑small cell lung cancer. The agency’s pilot program shortened the regulatory timeline for the label expansion, bringing a new targeted oral option to a lung cancer population with limited first‑line therapies. The decision highlights the agency’s experimental review pathways and will have commercial and prescribing implications for HER2‑driven thoracic oncology.