Boehringer awarded FDA Commissioner's National Priority Voucher for HERNEXEOS® in HER2 lung cancer

RIDGEFIELD, Conn. , Nov. 7, 2025 /PRNewswire/ -- The U.S. Food & Drug Administration (FDA) has awarded a Commissioner's National Priority Voucher (CNPV) for HERNEXEOS ® (zongertinib tablets), currently under investigation for first-line use in treatment-naïve patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC). The CNPV program aims to shorten the review process from what normally takes 10-12 months to 1-2 months, while maintaining FDA's rigorous safety and efficacy standards.

"We are grateful to the FDA for this recognition and for the opportunity to bring HERNEXEOS, a potential new first-line treatment option, to patients with advanced HER2 NSCLC through the CNPV program, an innovative FDA pilot initiative," said Jean-Michel Boers, U.S. Country Managing Directo