FDA Grants Accelerated Approval to Zongertinib for Unresectable or Metastatic Non-squamous Non-small Cell Lung Cancer

On February 26, the FDA granted accelerated approval to zongertinib, a kinase inhibitor, for an expanded indication 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-authorized test.

For more information, read the FDA announcement and visit the Boehringer Ingelheim Pharmaceuticals website.

Posted on 3/4/2026