FDA Approves Sevabertinib in Non-Squamous NSCLC

The FDA has granted accelerated approval to the kinase inhibitor sevabertinib (Hyrnuo) for the treatment of adult patients with locally advanced or metastatic, non-squamous non–small cell lung cancer (NSCLC) with HER2 (ERBB2) tyrosine kinase domain (TKO) activating mutations and who have received a prior systemic therapy, according to a release from the FDA.¹

Additionally, the Oncomine Dx Target Test has also been approved by the FDA as a companion diagnostic device to aid in detecting HER2 (ERBB2) TKD activating mutations in those with non-squamous NSCLC who may be eligible for sevabertinib.

Sevabertinib was evaluated in this indication in the open-lable, single-arm phase 1/2 SOHO-01 trial (NCT05099172), in which patients with locally advanced or metastatic NSCLC with HER2 (ERBB2) TKD activating mutations who had prior systemic therapy received sevabertinib. Most recent results from the trial were presented at the European Society of Medical Oncology (ESMO) 2025 Congress.²

Among the 70 patients who were naive to therapy targeting HER2 mutations, the confirmed objective response rate (ORR) was 71% (95% CI, 59%-82%), and the median duration of response (DOR) was 9.2 months (95% CI, 6.3-15.0); 54% of patients had a DOR of 6 months or more.

Among the 52 patients who received prior systemic therapy including HER2-targeted antibody drug conjugates, the ORR was 38% (95% CI, 25%-53%), with a median DOR of 7.0 months (95% CI, 5.6-not evaluable); 60% of patients had a DOR of at least 6 months.

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

The prescribing information has warnings and precautions for diarrhea, interstitial lung disease/pneumonitis, hepatotoxicity, ocular toxicity, embryo-fetal toxicity, and pancreatic enzyme elevation.

Previously, in May 2025, the FDA granted priority review to a new drug application for sevabertinib in patients with previously treated advanced HER2-mutant NSCLC.³

References

1. FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer. News release. FDA. November 19, 2025. Accessed November 19, 2025. https://tinyurl.com/mt455knh

Le X, Kim TM, Dong X, et al. Sevabertinib (BAY 2927088) in advanced HER2-mutant non-small cell lung cancer (NSCLC): results from the SOHO-01 study. Presented at the 2025 European Society for Medical Oncology Congress. Presented at the 2025 ESMO Congress; October 17–20, 2025; Berlin, Germany. Abstract LBA75.

1. U.S. FDA accepts new drug application under priority review for sevabertinib (BAY 2927088) in HER2-mutant non-small cell lung cancer. News release. Bayer. May 28, 2025. Accessed November 19, 2025. https://tinyurl.com/2t5vb5ky