The FDA has granted Priority Review to the New Drug Application for zongertinib (BI 1810631) for the treatment of adults with unresectable or metastatic non–small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) mutations and who have received prior systemic therapy, according to an announcement from Boehringer Ingelheim. The Prescription Drug User Fee Act (PDUFA) action date is in the third quarter of 2025, officials said. If approved, zongertinib would be the first orally administered, targeted therapy for patients with previously treated HER2-mutated advanced NSCLC, according to the announcement. ...
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