The FDA granted accelerated approval to Hernexeos (zongertinib) on February 26, 2026, for adults with unresectable or metastatic non-squamous NSCLC with HER2 tyrosine kinase domain mutations as a first-line treatment.135
This is the second approval under the Commissioner's National Priority Voucher (CNPV) program, following USAntibiotics’ Augmentin XR in December 2025; the application was filed January 13, 2026, with approval in just six weeks.125
Efficacy from Phase 1b Beamion LUNG-1 trial (N=72 treatment-naïve patients):
76% objective response rate (11% complete, 65% partial), 64% with response lasting ≥6 months.123
Hernexeos, an oral HER2 kinase inhibitor, was previously approved in August 2025 for previously treated patients; continued approval requires confirmatory trial like Beamion LUNG-2.125
The CNPV program has faced criticism for lack of transparency from Rep. Jake Auchincloss.1
Sources:
1. https://www.biospace.com/fda/boehringer-wins-speedy-lung-cancer-approval-under-commissioners-priority-program
2. https://www.pharmexec.com/view/fda-approves-hernexeos-national-priority-voucher-program
3. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-unresectable-or-metastatic-non-squamous-non-small-cell
5. https://www.fda.gov/news-events/press-announcements/fda-grants-second-approval-under-national-priority-voucher-pilot-program