Documentary record · ACCELERATED APPROVAL — INDICATION EXPANSION
Sevabertinib (Hyrnuo) accelerated approval expanded to first-line HER2-mutant non-squamous lung cancer
ACCELERATED APPROVAL EXPANDED — CONFIRMATORY TRIAL ONGOING
Event date
September 9, 2026
Jurisdiction
United States
Issuing body
U.S. Food and Drug Administration
Action type
ACCELERATED APPROVAL — INDICATION EXPANSION
Lifecycle state
ACCELERATED APPROVAL EXPANDED — CONFIRMATORY TRIAL ONGOING
Verification date
15 September 2026
Legal effect
An expansion of an existing accelerated approval, not a new drug approval. Continued approval may depend on the confirmatory SOHO-02 trial.
What this establishes
- FDA granted accelerated approval to sevabertinib for adults with locally advanced or metastatic non-squamous NSCLC with HER2 (ERBB2) tyrosine-kinase-domain activating mutations detected by an FDA-authorized test, removing the earlier requirement of prior systemic therapy.
- Sevabertinib first received accelerated approval in November 2025 for previously treated patients.
- The expansion rests on 69 treatment-naïve patients in SOHO-01 (confirmed objective response rate 75%).
What this does not establish
- A survival benefit, which the confirmatory trial is designed to test.
- Coverage.
Why it matters
A single-arm response rate now supports first-line use. That is exactly the evidentiary trade-off accelerated approval is built to make, and to revisit.
Primary source
Related on this site
Register: the record store · record id fda-sevabertinib-first-line-2026-09-09.