The FDA has granted accelerated approval to Hernexeos (zongertinib) for certain adults with advanced non-small cell lung cancer (NSCLC), marking the second approval under the Commissioner’s National Priority Voucher (CNPV) pilot program. The application was filed on January 13, 2026, and a final decision was issued 44 days later.
Hernexeos is now approved for adults with unresectable or metastatic non-squamous NSCLC whose tumors harbor HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test. The new accelerated approval extends use of the drug to patients who have not received prior systemic therapy. Hernexeos had previously received accelerated approval in August 2025 for patients with the same mutation profile who had been treated previously.
In clinical trial data submitted to the FDA, 76% of previously untreated patients experienced a substantial decrease in tumor size, compared with an expected response rate of 30% to 45% with standard care. The FDA noted that lung cancer remains the leading cause of cancer death in the United States, with an estimated 226,650 new cases and 124,730 deaths in 2025.
The CNPV pilot program is designed to expedite applications that address critical national health priorities by providing benefits such as enhanced communications and rolling review. Hernexeos received a national priority voucher on November 6, 2025, and was also granted Breakthrough Therapy and Priority Review designations.
Serious risks with Hernexeos include hepatotoxicity, left ventricular dysfunction, interstitial lung disease/pneumonitis, and embryofetal toxicity; common side effects include diarrhea, rash, fatigue, nausea, musculoskeletal pain, and upper respiratory tract infection. The accelerated approval was granted to Boehringer Ingelheim Pharmaceuticals, Inc.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!