Zongertinib would be the first orally administered, targeted therapy for previously treated patients with HER2 ( ERBB2 )-mutant advanced non-small cell lung cancer (NSCLC), if approved The application for this investigational treatment is based on positive results from the Phase Ib Beamion LUNG-1, Cohort 1 trial that demonstrated an objective response rate of 71% in 75 previously treated patients with advanced NSCLC HER2 ( ERBB2 )-mutant advanced NSCLC is linked to poor prognosis and currently has limited treatment options i RIDGEFIELD, Conn. and INGELHEIM, Germany , Feb. 19, 2025 /PRNewswire/ -- 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. "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 res.
