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

Regulatory approval news: On Nov 19, 2025, the FDA granted accelerated approval to sevabertinib (Hyrnuo; Bayer), a kinase inhibitor, for adults with locally advanced or metastatic non-squamous NSCLC harboring HER2 (ERBB2) tyrosine kinase domain activating mutations detected by an FDA-approved test, after prior systemic therapy. Approval was supported by the single-arm SOHO-01 trial with confirmed ORR and DOR as key endpoints. FDA also approved the Oncomine Dx Target Test as a companion diagnostic.

FDA accelerated approval: sevabertinib for HER2 (ERBB2) TKD–mutant non-squamous NSCLC

Type: Regulatory approval (accelerated approval)

On Nov 19, 2025, the FDA granted accelerated approval to sevabertinib (Hyrnuo; Bayer HealthCare Pharmaceuticals Inc.), a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.

The FDA also approved the Oncomine Dx Target Test (Life Technologies Corporation) as a companion diagnostic to aid detection of HER2 (ERBB2) TKD activating mutations in patients with non-squamous NSCLC who may be eligible for sevabertinib.

Supporting evidence (SOHO-01; NCT05099172)

Efficacy was evaluated in SOHO-01, an open-label, single-arm, multicenter, multi-cohort study in unresectable/metastatic non-squamous NSCLC with HER2 (ERBB2) TKD activating mutations after prior systemic therapy. Primary outcomes were confirmed ORR and DOR by BICR (RECIST v1.1).

  • HER2-targeted therapy–naïve (n=70): ORR 71% (95% CI 59–82); median DOR 9.2 months (95% CI 6.3–15.0); 54% of responders had DOR ≥6 months.
  • Prior HER2-targeted ADCs (n=52): ORR 38% (95% CI 25–53); median DOR 7.0 months (95% CI 5.6–not evaluable); 60% of responders had DOR ≥6 months.

Label highlights

Warnings/precautions include diarrhea, hepatotoxicity, ILD/pneumonitis, 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; reviews at collaborating agencies were reported as ongoing.

Sources