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.