FDA Grants Second National Priority Voucher-Driven Approval for Hernexeos in HER2-Mutant NSCLC
The FDA approved Hernexeos (zongertinib) for adults with unresectable or metastatic non-squamous NSCLC harboring activating HER2 (ERBB2) mutations, extending accelerated approval to first-line patients under the Commissioner's National Priority Voucher (CNPV) pilot program. The decision followed strong data showing 76% of untreated patients had substantial tumor shrinkage, higher than typical 30-45% responses, and came 44 days after filing on Jan 13, 2026. The move underscores fast-tracked review through the CNPV program, which also provides voucher-related benefits; the agency noted Breakthrough Therapy and Priority Review designations and highlighted safety risks such as hepatotoxicity and other common side effects.