FDA Approval

FDA Expands Hyrnuo Accelerated Approval in HER2-Mutated Advanced Non–Small Cell Lung Cancer

Edited by:
Anthony Calabro, MA

Key Highlights

  • The expanded indication covers tumors with HER2 (ERBB2) tyrosine kinase domain–activating mutations.
  • The confirmed objective response rate was 75% among 69 patients without previous systemic therapy.
  • Among responding patients, 73% had responses lasting at least 6 months.
  • The recommended dose is 20 mg orally twice daily with food.

The FDA granted accelerated approval to sevabertinib (Hyrnuo, Bayer Healthcare Pharmaceuticals Inc.), a kinase inhibitor, for adults with locally advanced or metastatic nonsquamous non–small cell lung cancer whose tumors harbor HER2 (ERBB2) tyrosine kinase domain–activating mutations detected by an FDA-authorized test. The action expands a previous accelerated approval limited to patients who had received systemic therapy.

Efficacy was evaluated in SOHO-01 (NCT05099172), an open-label, single-arm, multicenter, multicohort trial. Mutations were identified in tumor tissue or plasma by local laboratories before enrollment. Among 69 patients who had not received previous systemic therapy, the confirmed objective response rate was 75% (95% CI, 64%-85%), as assessed through blinded independent central review using RECIST version 1.1. Among responders, 73% had a duration of response of at least 6 months and 38% had a duration of at least 12 months.

The prescribing information includes warnings and precautions for diarrhea, hepatotoxicity, interstitial lung disease or pneumonitis, left ventricular dysfunction, ocular toxicity, elevated pancreatic enzyme levels, and embryo-fetal toxicity.

The recommended sevabertinib dosage is 20 mg orally twice daily with food. Treatment should continue until disease progression or unacceptable toxicity. The review was conducted through Project Orbis in collaboration with the United Kingdom’s Medicines and Healthcare products Regulatory Agency; reviews at other participating regulatory agencies remained ongoing.

Reference
US Food and Drug Administration. FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous non-small cell lung cancer. Published September 9, 2026. Accessed September 15, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-locally-advanced-or-metastatic-non-squamous-non-small