BioSpace

Boehringer Wins Speedy Lung Cancer Approval Under Commissioner’s Priority Program

The FDA granted accelerated approval to Boehringer Ingelheim’s oral HER2 kinase inhibitor Hernexeos six weeks after the company filed its application, marking the second approval under the new Commissioner’s National Priority Voucher (CNPV) program. The decision expands Hernexeos use to treatment‑naïve patients with unresectable or metastatic non‑small cell lung cancer, based on Phase 1b Beamion LUNG‑1 data showing a 76% overall response rate and durable responses in 64% of patients. The CNPV voucher accelerated the review from the typical 10‑12 months to roughly one to two months, but the program faces scrutiny after a recent high‑profile rejection of another voucher‑backed drug. Boehringer will need to complete a confirmatory trial to retain the accelerated approval.