
7 November 2025 - The US FDA has awarded a Commissioner's National Priority Voucher 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.
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.