FDA Gives Accelerated Approval to Sevabertinib in HER2+ NSCLC

The FDA has granted accelerated approval to sevabertinib (Hyrnuo) as a treatment for those with locally advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC) harboring HER2 tyrosine kinase domain (TKD)–activating mutations as detected by an approved test, according to a news release from the agency.¹

This decision expands the availability of sevabertinib to the frontline setting. In November 2025, the FDA granted accelerated approval to sevabertinib as a treatment for those who received prior systemic therapy.²

Supporting data for the approval came from the phase 1/2 SOHO-01 trial (NCT05099172). Topline findings revealed that, among 69 patients who did not receive any prior systemic therapy, sevabertinib yielded an objective response rate (ORR) of 75% (95% CI, 64%-85%). Additionally, 73% of those with a response achieved a duration of response of at least 6 months, and 38% had responses sustained for at least 12 months.

Prescribing information for the drug includes warnings and precautions for diarrhea, interstitial lung disease, hepatotoxicity, left ventricular dysfunction, ocular toxicity, pancreatic enzyme elevation, and embryo-fetal toxicity. The agency approved sevabertinib at a dose of 20 mg orally twice daily with food until unacceptable toxicity or progressive disease.

The FDA previously granted priority review to frontline sevabertinib in May 2026.³

References

1. FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous non-small cell lung cancer. News release. FDA. September 9, 2026. Accessed September 9, 2026. https://tinyurl.com/mwsay6jf
2. FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer. News release. FDA. November 19, 2025. Accessed September 9, 2026. https://tinyurl.com/mt455knh
3. U.S. FDA grants priority review to supplemental new drug application for HYRNUO (sevabertinib) under investigation as a first-line treatment of HER2-mutated non-small cell lung cancer. News release. Bayer. May 18, 2026. Accessed September 9, 2026. https://tinyurl.com/mtjducst