Posted by Michael Wonder on 19 Nov 2025
FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer
19 November 2025 - Today, the FDA granted accelerated approval to sevabertinib (Hyrnuo, Bayer HealthCare Pharmaceuticals), a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer whose tumours have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA approved test, and who have received a prior systemic therapy.
The FDA also approved the Oncomine Dx Target Test (Life Technologies Corporation) as a companion diagnostic device to aid in detecting HER2 (ERBB2) tyrosine kinase domain activating mutations in patients with non-squamous non-small cell lung cancer who may be eligible for treatment with sevabertinib.
