FDA grants accelerated approval to sevabertinib for non-squamous non-small cell

On November 19, 2025, the Food and Drug Administration granted accelerated approval to Bayer’s (BAYRY) sevabertinib, a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. FDA also approved the Oncomine Dx Target Test as a companion diagnostic device to aid in detecting HER2 TKD activating mutations in patients with non-squamous NSCLC who may be eligible for treatment with sevabertinib. Efficacy was evaluated in patients with unresectable or metastatic, non-squamous NSCLC with HER2 TKD activating mutations who had received prior systemic therapy and received sevabertinib in SOHO-01, an open-label, single-arm, multicenter, multi-cohort clinical trial. HER2 activating mutations were determined in tumor tissue or plasma by local laboratories prior to enrollment. The major efficacy outcome measures were confirmed objective response rate and duration of response as assessed by BICR using RECIST v1.1. The recommended sevabertinib dose is 20 mg orally twice daily with food until disease progression or unacceptable toxicity.