Boehringer’s zongertinib receives Priority Review from U.S. FDA

Boehringer Ingelheim today 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.