Bayer's Sevabertinib (Hyrnuo) Secures FDA Accelerated Approval as First-Line Treatment for HER2-Mutant Advanced NSCLC
On September 9, 2026, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Bayer's oral tyrosine kinase inhibitor (TKI) sevabertinib (Hyrnuo) as a first-line treatment option for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors harbor human epidermal growth factor receptor 2 (HER2/ERBB2) tyrosine kinase domain (TKD) activating mutations.
The decision, which followed FDA Priority Review and Breakthrough Therapy Designations, represents a major advance in precision oncology for a distinct subset of lung cancer patients who historically face poor prognoses and limited treatment options.
Clinical Efficacy in SOHO-01
The accelerated approval is supported by efficacy data from a treatment-naïve patient cohort (N=69) enrolled in the ongoing Phase I/II SOHO-01 clinical trial (NCT05099172). Key results from this cohort include:
- Objective Response Rate (ORR): 75%, consisting of a 6% complete response (CR) rate and a 70% partial response (PR) rate.
- Duration of Response (DOR): Highly durable, with 73% of responding patients maintaining their response for at least 6 months.
The safety profile of sevabertinib was consistent with previous clinical evaluations.
Precision TKI Mechanism and Confirmatory Path
Sevabertinib is an oral, reversible, small-molecule TKI that potently inhibits mutant human HER2, including HER2 exon 20 insertions and HER2 point mutations. Derived from Bayer's strategic research alliance with the Broad Institute of MIT and Harvard, its reversible binding mechanism is designed to provide precise target control and potentially reduce long-term side effects compared to irreversible TKIs.
To transition this accelerated approval into traditional approval, Bayer is conducting the ongoing Phase III SOHO-02 confirmatory trial (NCT06452277). This global, randomized study is evaluating the efficacy and safety of sevabertinib versus the standard of care as a first-line therapy in patients with advanced HER2-mutant NSCLC.
This approval expands on sevabertinib's prior accelerated approval in November 2025 for previously treated advanced HER2-mutant NSCLC, moving the targeted therapy directly into the front-line setting.