Whippany, N.J. — Bayer announced that the U.S. Food and Drug Administration has granted accelerated approval to HYRNUO (sevabertinib) as a first-line treatment for certain patients with HER2-mutated non-small cell lung cancer.
The approval covers adults with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors have HER2/ERBB2 tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.
HYRNUO is an oral, reversible small-molecule tyrosine kinase inhibitor. The first-line approval follows FDA Priority Review and Breakthrough Therapy Designation.
The accelerated approval was based on objective response rate and duration of response results from 69 treatment-naïve patients in Cohort F of the ongoing Phase I/II SOHO-01 trial.
In the cohort, the objective response rate was 75%, including complete responses in 6% of patients and partial responses in 70%. Among responders, 73% maintained a response for at least six months and 38% maintained a response for at least 12 months.
Continued approval may depend on verification of clinical benefit in the ongoing Phase III SOHO-02 confirmatory trial, which is evaluating HYRNUO against standard of care in treatment-naïve patients with advanced HER2-mutated non-small cell lung cancer.
The safety profile was consistent with previous findings. The most common adverse reactions reported in patients receiving HYRNUO were diarrhea, rash, stomatitis, paronychia, nausea and decreased weight.
“The FDA’s accelerated approval of HYRNUO marks an important advance for treatment-naïve patients with HER2-mutated NSCLC,” said Xiuning Le, M.D., Ph.D., associate professor of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center and lead investigator of SOHO-01. “This milestone also underscores the critical importance of comprehensive molecular testing at diagnosis, including for activating HER2 mutations, to ensure patients receive the most appropriate treatment as early as possible.”
“Today’s FDA approval of HYRNUO as an initial treatment option for locally advanced or metastatic non-squamous HER2-mutated NSCLC is an important milestone for patients and a powerful validation of Bayer’s commitment to advancing precision oncology in areas with the highest unmet needs,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “Lung cancer remains the leading cause of cancer-related deaths worldwide and for patients with HER2-mutated NSCLC, a distinct subtype that often affects people who have never smoked, there remains a critical need for additional treatment options. This approval underscores the potential of precision medicine to transform outcomes by matching the right patients to the right therapy at the right time.”
HYRNUO previously received accelerated FDA approval in November 2025 for patients with locally advanced or metastatic NSCLC with HER2 tyrosine kinase domain activating mutations who had received prior systemic therapy.
The drug inhibits mutated HER2, including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors. HYRNUO originated from Bayer’s research alliance with the Broad Institute of MIT and Harvard.
