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  6. FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous non-small cell lung cancer
  1. Resources for Information | Approved Drugs

FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous non-small cell lung cancer

On September 9, 2026, the Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo, Bayer Healthcare Pharmaceuticals Inc.), a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.

This approval expands the existing indication for sevabertinib, which was previously granted accelerated approval for adult patients with locally advanced or metastatic non-squamous NSCLC with HER2 (ERBB2) TKD activating mutations who had received prior systemic therapy.

Full prescribing information for Hyrnuo will be posted on Drugs@FDA.

Efficacy and Safety

Efficacy was evaluated in patients with locally advanced or metastatic, non-squamous NSCLC with HER2 (ERBB2) TKD activating mutations who received sevabertinib in SOHO-01 (NCT05099172), an open-label, single-arm, multicenter, multi-cohort clinical trial. HER2 (ERBB2) 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 (ORR) and duration of response (DOR) as assessed by blinded independent central review (BICR) using RECIST v1.1. Among 69 patients with locally advanced or metastatic NSCLC with HER2 (ERBB2) TKD activating mutations who had not received prior systemic therapy, the ORR was 75% (95% CI: 64, 85); 73% of responding patients had a DOR of ≥6 months and 38% had a DOR of ≥12 months.

The prescribing information includes warnings and precautions for diarrhea, hepatotoxicity, interstitial lung disease (ILD)/pneumonitis, left ventricular dysfunction, ocular toxicity, pancreatic enzyme elevation, and embryo-fetal toxicity.

Recommended Dosage

The recommended sevabertinib dose is 20 mg orally twice daily with food, until disease progression or unacceptable toxicity.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). The application reviews are ongoing at the other regulatory agencies.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

This application was granted priority review. Sevabertinib received breakthrough therapy designation and orphan drug designation. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

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