Bayer announces HYRNUO sNDA granted Priority Review status by FDA

Bayer (BAYRY) announced that the U.S. Food and Drug Administration has granted HYRNUO Priority Review status for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations in patients with no prior therapy. HYRNUO is not currently approved in this first-line setting. In November 2025, HYRNUO received U.S. FDA accelerated approval for patients with locally advanced or metastatic NSCLC whose tumors have HER2 TKD activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The regulatory application for first-line use of HYRNUO is based on preliminary clinical evidence from Cohort F of the ongoing Phase I/II SOHO-01 Study evaluating the efficacy and safety of HYRNUO in patients with locally advanced or metastatic HER2-mutated NSCLC.