WHIPPANY, N.J. — Bayer said the U.S. Food and Drug Administration has granted Priority Review to a supplemental new drug application for HYRNUO as a potential first-line treatment for certain patients with non-small cell lung cancer.
The application covers adult patients with locally advanced or metastatic non-small cell lung cancer whose tumors have HER2, or ERBB2, tyrosine kinase domain activating mutations and who have not received prior therapy. HYRNUO is not currently approved for first-line use.
Bayer said the submission is based on preliminary clinical evidence from Cohort F of the ongoing Phase I/II SOHO-01 trial, which is evaluating the safety and efficacy of HYRNUO in patients with locally advanced or metastatic HER2-mutated non-small cell lung cancer. Cohort F includes patients who had not previously received treatment.
“The U.S. FDA’s decision to grant Priority Review for HYRNUO is an important milestone as we continue to study this investigational treatment option in HER2-mutated non-small cell lung cancer,” said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division. “We look forward to working closely with regulatory authorities as they review the data supporting this application for use in the first-line setting.”
HYRNUO received accelerated approval from the FDA in November 2025 for patients with locally advanced or metastatic non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. That approval was based on objective response rate and duration of response, and continued approval may depend on verification of clinical benefit in a confirmatory trial.
“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,” said Nelson Ambrogio, President, Bayer U.S. Pharmaceuticals. “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.”
HYRNUO is an oral, reversible small-molecule tyrosine kinase inhibitor that targets mutated human HER2, including HER2 exon 20 insertions and HER2 point mutations. It also inhibits epidermal growth factor receptors, with selectivity for mutated versus wild-type EGFR. Bayer said the drug works by blocking certain tyrosine kinase enzymes involved in cancer cell growth.
HYRNUO was developed from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, Massachusetts.
Non-small cell lung cancer is the most common type of lung cancer, accounting for more than 85% of lung cancer cases. Activating HER2 mutations are found in 2% to 4% of patients with advanced non-small cell lung cancer.
