FDA News Release
FDA Grants Second Approval under the National Priority Voucher Pilot Program
- For Immediate Release:
The U.S. Food and Drug Administration today issued an approval for the lung cancer drug Hernexeos (zongertinib) as a part of the new Commissioner's National Priority Voucher (CNPV) pilot program. The application was filed on January 13, 2026.
In the clinical trial data submitted to the agency, a remarkable 76% of previously untreated patients had a substantial decrease in tumor size, representing a significant improvement from the current standard of care whereby 30-45% of patients are typically expected to demonstrate this response.
“As a part of the national priority voucher program, the FDA is on the hunt for game-changing therapies that can qualify for a priority review. In this case a final decision was rendered 44 days after the filing date,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Patients and sponsors deserve an efficient FDA process that cuts out idle time and delivers powerful treatments safely and quickly for the American people.”
Lung cancer kills more Americans annually than any other type of cancer, with an estimated 226,650 new diagnoses and 124,730 deaths in 2025, according to the National Cancer Institute. Hernexeos targets molecular alterations found in a certain subset of non-small cell lung cancers (NSCLC).
Hernexeos is now approved for adults with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations as detected by an FDA-authorized test. In August 2025, Hernexeos was granted accelerated approval for adults with non-squamous NSCLC with these mutations who had received prior systemic therapy; today’s accelerated approval extends this treatment option to patients who have not received prior therapy.
Based on preliminary data, Hernexeos was proactively granted a national priority voucher by the FDA on November 6, 2025. The CNPV pilot program seeks to expedite approval of applications that address critical national health priorities, such as bringing innovative therapies to the American people, addressing large unmet medical needs, promoting domestic manufacturing, and increasing affordability. A company selected for the program is issued a voucher entitling the company to benefits including enhanced communications and rolling review to allow for a shortened review time.
The FDA granted Hernexeos Breakthrough Therapy and Priority Review designations.
Serious side effects associated with Hernexeos include hepatotoxicity, left ventricular dysfunction, interstitial lung disease/pneumonitis, and embryofetal toxicity. The most common side effects include diarrhea, rash, hepatotoxicity, fatigue, nausea, musculoskeletal pain, and upper respiratory tract infection.
The FDA granted the accelerated approval to Boehringer Ingelheim Pharmaceuticals, Inc.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.