FDA Grants Accelerated Approval to Zongertinib for Non-Squamous NSCLC With HER2 TKD Activating Mutations

On August 8, the FDA granted accelerated approval to zongertinib, a kinase inhibitor, for adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.

For more information, read the FDA announcement and the Boehringer Ingelheim Pharmaceuticals press release.

Posted on 8/18/2025