FDA
FDA grants accelerated approval to Hyrnuo for non-squamous non-small cell lung cancer
Brand name: Hyrnuo
Generic name: sevabertinib
Manufacturer: Bayer Healthcare Pharmaceuticals
Approval date: November 19, 2025
FDA granted accelerated approval to Hyrnuo (sevabertinib), a kinase inhibitor, for adults 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-approved test, and who have received a prior systemic therapy.
FDA also approved the Oncomine Dx Target Test (Life Technologies Corporation) as a companion diagnostic device to aid in detecting HER2 (ERBB2) TKD activating mutations in patients with non-squamous NSCLC who may be eligible for treatment with sevabertinib.
Efficacy
Efficacy was evaluated in patients with unresectable or metastatic, non-squamous NSCLC with HER2 (ERBB2) TKD activating mutations who’d received prior systemic therapy and 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 labs prior to enrollment.
Major efficacy outcome measures were confirmed objective response rate (ORR) and duration of response (DOR) as assessed by Blinded Independent Central Review using RECIST v1.1. Among 70 patients with locally advanced or metastatic NSCLC with HER2 (ERBB2) TKD activating mutations who had received prior systemic therapy but were naive to therapy targeting HER2 mutations, ORR was 71% (95% confidence interval [CI], 59-82), with a median DOR of 9.2 months (95% CI, 6.3-15.0), and 54% of responding patients having a DOR of ≥ 6 months.
Among 52 patients with locally advanced or metastatic NSCLC with HER2 (ERBB2) TKD activating mutations who had received prior systemic therapy including HER2-targeted antibody drug conjugates, ORR was 38% (95% CI, 25-53), with a median DOR of 7.0 months (95% CI, 5.6, not evaluable), and 60% of responding patients having a DOR of ≥ 6 months.
Safety
The most common adverse reactions (>20%) in the trial were diarrhea, rash, paronychia, stomatitis, and nausea.
The prescribing information includes warnings and precautions for diarrhea, hepatotoxicity, interstitial lung disease (ILD)/pneumonitis, ocular toxicity, pancreatic enzyme elevation, and embryo-fetal toxicity.
Recommended dose
The recommended dosage of sevabertinib is 20 mg orally twice daily with food until disease progression or unacceptable toxicity.
Sources:
FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer. [News release]. 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-non-squamous-non-small-cell-lung-cancer
Hyrnuo (sevabertinib) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219972s000lblCorrected.pdf Revised November 2025. Accessed November 24, 2025.