The U.S. Food and Drug Administration (FDA) has granted Priority Review to Boehringer Ingelheim’s new drug application for zongertinib (BI 1810631) for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) mutations and who have received prior systemic therapy.

The FDA grants Priority Review to applications for drugs that would offer significant improvements in the treatment, diagnosis, or prevention of serious conditions, with action expected within six months compared to 10 months under standard review. The Prescription Drug User Fee Act (PDUFA) action date is in the third quarter of 2025.

“We believe zongertinib has the potential to transform the care of previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer and are hopeful about the continued research in other tumor types and lines of therapy,” said Shashank Deshpande, Member of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “Priority Review illustrates the urgent need in this patient population and the possibility for zongertinib to be a groundbreaking innovation for patients with limited treatment options.”

The application was based on Phase Ib Beamion LUNG-1 trial results. Cohort 1 (N=75) showed an objective response rate of 71%, six-month progression-free survival of 69%, and duration of response of 73% in patients with HER2 tyrosine kinase domain mutations. Zongertinib had a low safety profile, with only 5% dose reductions and 3% treatment discontinuations. Most TRAEs were mild, with diarrhea and rash being the most common. No new safety signals were observed. Grade 3 or higher TRAEs occurred in one patient, and no treatment-related interstitial lung disease cases were reported.

Zongertinib was previously granted Breakthrough Therapy Designation and Fast Track Designation by the FDA. In addition to the FDA designations, Japan’s Pharmaceuticals and Medical Devices Agency recently granted Orphan Drug Designation to zongertinib.