The FDA granted accelerated approval to Boehringer Ingelheim’s Hernexeos (zongertinib tablets) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors harbor HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.

The approval comes under the National Priority Voucher Program, joining Augmentin XR as one of the few approvals from the voucher program as of February 27, 2026. Hernexeos was granted a national priority voucher by the FDA back on November 6, 2025.²

“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.”

What is Hernexeos?

Hernexeos is an irreversible tyrosine kinase inhibitor designed to inhibit HER2 (ERBB2) while sparing wild-type EGFR. It is also being evaluated in additional trials, including Beamion LUNG-3 (NCT07195695), a Phase III study investigating Hernexeos as adjuvant monotherapy in patients with early-stage, resectable HER2-mutant NSCLC.

What is FDA’s approval of Hernexeos based on?

The approval is based on objective response rate and duration of response from a cohort of treatment-naïve patients (N=72) in the Phase Ib Beamion Lung-1 trial.¹

Hernexeos demonstrated an objective response rate of 76%, including 11% complete responses and 65% partial responses. A duration of response of at least six months was observed in 64% of patients. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.¹

Boehringer is currently enrolling patients in Beamion Lung-2 a Phase III study evaluating Hernexeos as a first-line treatment for this population. The data builds on the FDA’s accelerated approval of Hernexeos in August 2025 for previously treated patients with HER2-mutant advanced NSCLC.¹

“Zongertinib is setting a new standard as the first targeted therapy for treatment naïve patients with HER2-mutant advanced non-small cell lung cancer with demonstrated efficacy, a manageable safety profile, and once daily oral administration,” said Dr. John Heymach, coordinating investigator for the Beamion Lung-1 trial and chair of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center. “Now these patients finally have a targeted treatment option that they can receive immediately following identification of a HER2 mutation.”

“With Hernexeos now approved for patients with HER2-mutant advanced NSCLC as an initial treatment option, we are delivering on our promise to transform care for people with this rare and aggressive cancer,” said Shashank Deshpande, chairman of the board of managing directors and head of human pharma at Boehringer Ingelheim. “This approval marks a shift towards personalized care with a targeted treatment option for patients with HER2 mutated lung cancer.”

Why did Boehringer Ingelheim focus on HER2 treatments?

HER2 (ERBB2) mutations occur in approximately 2–4% of NSCLC cases and are associated with poor prognosis and a higher incidence of brain metastases. Alterations in the HER2 gene can trigger uncontrolled cell proliferation, inhibit cell death and promote tumor growth and spread.¹

“We first learned about the HER2 genetic mutation as a lung cancer driver in a small subset of patients more than 20 years ago,” said Danielle Hicks, chief patient officer of GO2 for Lung Cancer. “Half of these people do not respond to the current standard of care, which is why it is vital to provide them with a treatment option that has been designed specifically for their disease.”

Hernexeos demonstrated a manageable safety profile consistent with that observed in previously treated patients, while adverse events led to dose discontinuations in 6% of patients.¹

In a pooled safety population of 292 patients with HER2 (ERBB2)-mutant NSCLC, the most common adverse reactions occurring in more than 20% of patients were diarrhea (54%), rash (28%), hepatotoxicity (27%), fatigue (25%), nausea (23%), musculoskeletal pain (21%) and upper respiratory tract infection (20%).¹

Sources

1. FDA approves Hernexeos, the first targeted therapy for adults with HER2-mutant advanced NSCLC as an initial treatment option Boehringer Ingelheim February 26, 2026 https://www.boehringer-ingelheim.com/human-health/cancer/lung-cancer/fda-approves-hernexeos-first-line-lung-cancer
2. FDA Grants Second Approval under the National Priority Voucher Pilot Program U.S. Food and Drug Administration https://www.fda.gov/news-events/press-announcements/fda-grants-second-approval-under-national-priority-voucher-pilot-program