HYRNUO (sevabertinib) - (SOHO-01)

May 16, 2026: Bayer announced the FDA granted Priority Review for HYRNUO (sevabertinib) for first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations and who have received no prior therapy. The submission is supported by preliminary evidence from Cohort F (treatment-naïve patients) of the ongoing Phase I/II SOHO-01 trial (NCT05099172) evaluating efficacy and safety in HER2-mutated NSCLC; no efficacy outcomes were provided in the release.

Bayer noted HYRNUO previously received FDA accelerated approval in November 2025 for locally advanced or metastatic non-squamous NSCLC with HER2 TKD activating mutations (as detected by an FDA-approved test) after prior systemic therapy, based on ORR and DOR, with continued approval contingent on confirmatory clinical benefit.

The release also summarized key labeled safety risks from SOHO-01, including high rates of diarrhea, hepatotoxicity, ILD/pneumonitis, ocular toxicity, and pancreatic enzyme elevations. No FDA action date was stated.