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.
- FDA Grants Second Approval under the National Priority Voucher Pilot Program fda.gov
- Boehringer's Hernexeos secures speedy first-line expansion in FDA's 2nd national priority nod Fierce Pharma
- FDA approves HERNEXEOS®, the first targeted therapy for adults with HER2-mutant advanced NSCLC as an initial treatment option Yahoo Finance
- US FDA approves first-line use of Boehringer Ingelheim's lung cancer drug Reuters
- Advanced Nonsquamous NSCLC: FDA Grants Accelerated Approval to Zongertinib The ASCO Post
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