FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous non-small cell lung cancer
Regulatory approval: On Sept 9, 2026, the FDA granted accelerated approval to sevabertinib (Hyrnuo; Bayer), a kinase inhibitor, for adults with locally advanced or metastatic non-squamous NSCLC whose tumors harbor HER2 (ERBB2) tyrosine kinase domain activating mutations detected by an FDA-authorized test. The decision expands a prior accelerated approval that was limited to patients who had received prior systemic therapy. Efficacy was supported by single-arm SOHO-01 data in previously untreated patients.
FDA accelerated approval (Sept 9, 2026)
The US FDA granted accelerated approval to sevabertinib (Hyrnuo; Bayer Healthcare Pharmaceuticals Inc.), a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.
This action expands a previous accelerated approval for the same molecularly defined population that was limited to patients after prior systemic therapy.
Supporting evidence
Efficacy was evaluated in SOHO-01 (NCT05099172), an open-label, single-arm, multicenter, multi-cohort trial. HER2 (ERBB2) activating mutations were identified in tumor tissue or plasma by local laboratories before enrollment. Major endpoints were confirmed objective response rate (ORR) and duration of response (DOR) by blinded independent central review (RECIST v1.1).
In 69 patients who had not received prior systemic therapy, ORR was 75% (95% CI, 64–85). Among responders, 73% had DOR ≥6 months and 38% had DOR ≥12 months.
Safety and dosing (label highlights)
Prescribing information includes warnings/precautions for diarrhea, hepatotoxicity, ILD/pneumonitis, left ventricular dysfunction, ocular toxicity, pancreatic enzyme elevation, and embryo-fetal toxicity. Recommended dose: 20 mg orally twice daily with food until progression or unacceptable toxicity.
The review was conducted under Project Orbis, with FDA collaboration with the UK MHRA; reviews at other agencies are ongoing.