FDA Grants Accelerated Approval to Sevabertinib for Non-squamous Non-small Cell Lung Cancer

On November 19, the FDA granted accelerated approval to sevabertinib, a kinase inhibitor, for adults with locally advanced 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 a prior systemic therapy.

For more information, read the FDA announcement and the Bayer press release.

Posted on 11/21/2025