The FDA expanded the label for Boehringer Ingelheim’s lung cancer drug Hernexeos under a National Priority Voucher pathway, granting an accelerated review and approval for first‑line use in HER2‑positive non‑small‑cell lung cancer. The program shortened review timelines and the approval came within 44 days, reflecting regulatory prioritization. Boehringer positioned the approval as a strategic win that broadens the drug’s market reach and may accelerate commercial uptake in a niche with limited options. The company emphasized that the accelerated pathway did not compromise safety standards and highlighted post‑market commitments. The case will be watched by other developers targeting small patient populations as regulators increasingly use priority mechanisms to speed access to therapies deemed of national interest.