Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to its 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."

Zongertinib had a safety profile with a low incidence of dose reductions (5%) and treatment discontinuations (3%).

"Personalized medicine has revolutionized cancer treatment," said GO2 for Lung Cancer's Chief Scientific Officer, Courtney Granville. "Early screening and biomarker testing for mutations provide critical information to guide targeted therapies in personalized medicine. This filing acceptance represents a significant step toward offering another option for individuals with a HER2 (ERBB2) diagnosis, bringing hope and direction to cancer patients."

Zongertinib was previously granted Breakthrough Therapy Designation and Fast Track Designation by the FDA. The FDA's Breakthrough Therapy designation is intended to expedite the development and review of a medicine that is intended to treat a serious or life-threatening disease, and preliminary clinical evidence indicates the drug may demonstrate substantial improvement over available treatments.

The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. In addition to the FDA designations, Japan's Pharmaceuticals and Medical Devices Agency recently granted Orphan Drug Designation to zongertinib.