Treats locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). NDA 219972, held by Bayer Healthcare. Sevabertinib.
As of Nov 14, 2026, NDA 219972 (Hyrnuo), held by Bayer Healthcare, was first approved by FDA on Nov 19, 2025, with 1 approved supplement and 0 published complete response letters.
HYRNUO is indicated for the treatment of 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 indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
| Sep 9, 2026 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Nov 19, 2025 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hyrnuo10MG · tablet;oral | Sevabertinib | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
