FDA grants accelerated approval to Zongertinib for HER2-mutated non-squamous NSCLC

New targeted therapy offers hope for patients with unresectable or metastatic NSCLC harboring HER2 tyrosine kinase domain activating mutations

Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to zongertinib (Hernexeos), a novel kinase inhibitor, for the treatment of adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors harbor HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.

The FDA also approved the Oncomine Dx Target Test (Life Technologies Corporation) as a companion diagnostic to identify eligible patients.

Approval was based on results from the Beamion LUNG-1 trial (NCT04886804), an open-label, multi-center, multi-cohort study that evaluated zongertinib in previously treated patients with advanced non-squamous NSCLC and HER2 TKD mutations.