Posted by Michael Wonder on 20 Feb 2025
Boehringer’s zongertinib receives priority review from US FDA for the treatment of HER2 (ERBB2)-mutant advanced non-small cell lung cancer
19 February 2025 - 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 non-small cell lung cancer.
Boehringer Ingelheim today announced that the US 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 whose tumours have HER2 (ERBB2) mutations and who have received prior systemic therapy.
