CNPV
February 26, 2026

FDA approves Boehringer Ingelheim’s Hernexeos (zongertinib) under the new Commissioner's National Priority Voucher pilot program

The FDA has given accelerated approval to Boehringer Ingelheim’s Hernexeos (zongertinib) for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test as part of the new Commissioner's National Priority Voucher pilot program.

  • CNPV awarded: Nov 6, 2025
  • Filing: Jan 13, 2026
  • Approved: Feb 26, 2026 (44 days from filing)

‍

Source: Press Release

Track every
FDA Priority Review Voucher Program.

Stay updated
Thank you!
Oops! Something went wrong while submitting your email.
HomeHistoryNewsCRL DashboardCNPV DashboardContactPRV Watch Pro
Privacy PolicyTerms and Conditions
Copyright © 2026 PRV Watch

This webpage has been compiled from manually reviewing thousands of documents from the U.S. Securities and Exchange Commission (SEC), U.S. Food and Drug Administrations (FDA), Federal Register, press releases and financial records. The information on this page has been compiled from publicly available sources only and does not include any undisclosed PRV issuance's, transactions or redemptions.

Stay in the loop

News, analysis, and insights from the world of Priority Review Vouchers.

Thank you!
Oops! Something went wrong while submitting your email.