Bayer recently announced that the US Food and Drug Administration (FDA) has granted HYRNUO (sevabertinib) Priority Review (PR) status for the first-line treatment of adult patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) whose tumors have HER2 (ERBB2) Tyrosine Kinase Domain (TKD) activating mutations in patients with no prior therapy. HYRNUO is not currently approved in this first-line setting.

In November 2025, HYRNUO received US 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 (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.

Christian Rommel, PhD, Head of Research and Development, Bayer’s Pharmaceuticals Division, said, “The US FDA’s decision to grant PR for HYRNUO is an important milestone as we continue to study this investigational treatment option in HER2-mutated NSCLC. We look forward to working closely with regulatory authorities as they review the data supporting this application for use in the first-line setting.

The regulatory application for first-line use of HYRNUO is based on preliminary clinical evidence from Cohort F (patients who had not previously received treatment) of the ongoing phase 1/2 SOHO-01 Study (NCT05099172) evaluating the efficacy and safety of HYRNUO in patients with locally advanced or metastatic HER2-mutated NSCLC.

Nelson Ambrogio, President, Bayer US Pharmaceuticals, said, “There continues to be progress in understanding and treating HER2-mutated NSCLC, and Bayer is committed to further investigating the full potential of HYRNUO as a treatment option. We appreciate the FDA’s Priority Review designation and remain focused on working through the regulatory process to help address the needs of this patient population.”