FDA Grants Accelerated Approval to Zongertinib in HER2+ NSCLC

The FDA has approved zongertinib (Hernexeos) as a treatment for adults with unresectable or metastatic nonsquamous non–small cell lung cancer (NSCLC) harboring HER2 tyrosine kinase domain–activating mutations under the new Commissioner’s National Priority Voucher (CNPV) pilot program, according to a press release from the FDA.¹

The supplemental new drug application was filed with the FDA on January 13, 2026. It was previously reported that the FDA awarded a CNPV to zongertinib for the treatment of patients with HER2-mutated NSCLC.²

Results from the phase 1b Beamion LUNG-1 trial (NCT04886804) evaluating zongertinib in patients with treatment-naive advanced NSCLC were recently shared at the European Society of Medical Oncology 2025 Congress. The data revealed that zongertinib yielded an objective response rate (ORR) of 76%. The FDA noted that the current standard of care typically yields an ORR of 30% to 45%.

“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 filling date,” said Marty Makary, MD, MPH, commissioner of the FDA.¹ “Patients and sponsors deserve an efficient FDA process that cuts out idle time and delivers powerful treatments safely and quickly for the American people.”

Regarding safety, serious adverse effects (AEs) associated with zongertinib were hepatotoxicity, left ventricular dysfunction, interstitial lung disease/pneumonitis, and embryofetal toxicity. The most common AEs were diarrhea, rash, hepatotoxicity, fatigue, nausea, musculoskeletal pain, and upper respiratory tract infection.

References

1. FDA grants second approval under the National Priority Voucher Pilot Program. News release. FDA. February 26, 2026. Accessed February 26, 2026. https://tinyurl.com/efhx9sr9
2. Boehringer awarded FDA Commissioner’s National Priority Voucher for zongertinib in patients with HER2-mutant NSCLC. News release. Boehringer Ingelheim. October 11, 2025. Accessed February 26, 2026. https://tinyurl.com/5h6sn5aj
3. FDA grants accelerated approval to zongertinib for non-squamous NSCLC with HER2 TKD activating mutations. News release. FDA. August 8, 2025. Accessed February 26, 2026. https://tinyurl.com/bdh2d4uc