FDA Grants Priority Review for Boehringer's Zongertinib NDA

The FDA has granted priority review to Boehringer Ingelheim's new drug application for zongertinib, aimed at treating unresectable or metastatic non-small cell lung cancer (NSCLC) in patients with HER2 (ERBB2) mutations who have previously undergone systemic therapy. This designation is indicative of zongertinib's potential to significantly improve treatment options for a patient population with limited alternatives, with action expected by the third quarter of 2025. Results from the Phase Ib Beamion LUNG-1 trial showed a 71% objective response rate among 75 participants, with a favorable safety profile, indicating a low incidence of dose reductions and treatment discontinuations. Shashank Deshpande from Boehringer Ingelheim expressed optimism about the drug's ability to transform care for these patients and ongoing research into other tumor types. Zongertinib would be the first orally administered targeted therapy for this specific group if approved. The drug has previously received Breakthrough Therapy Designation and Fast Track Designation from the FDA.