FDA Approves Bayer’s HYRNUO for First-Line HER2-Mutated Lung Cancer

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Bayer’s HYRNUO (sevabertinib) as a first-line treatment for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with HER2/ERBB2 tyrosine kinase domain (TKD) activating mutations.

The approval applies to patients whose tumors have the specific HER2 mutations confirmed through an FDA-authorized test. HYRNUO is an oral, reversible tyrosine kinase inhibitor (TKI) designed to target cancer cells carrying these mutations.

The FDA decision follows Priority Review and Breakthrough Therapy Designation for HYRNUO. The accelerated approval was based on results from the Phase I/II SOHO-01 trial, which evaluated the drug in patients with locally advanced or metastatic HER2-mutated NSCLC.

In the treatment-naïve Cohort F, which included 69 patients, HYRNUO achieved an objective response rate of 75%. Four patients had a complete response, while 48 had a partial response. Among patients who responded to treatment, 73% maintained their response for at least six months and 38% continued to respond for at least 12 months.

The FDA’s accelerated approval is based on objective response rate and duration of response. Continued approval will depend on the results of a confirmatory study showing clinical benefit.

Bayer is currently conducting the Phase III SOHO-02 trial, which is comparing HYRNUO with standard treatment in patients receiving first-line therapy for advanced HER2-mutated NSCLC. The study is intended to provide additional evidence of the drug’s clinical benefit.

The safety profile reported in SOHO-01 was consistent with earlier findings. Among 191 patients who received HYRNUO, the most common side effects occurring in more than 20% of patients were diarrhea, rash, inflammation of the mouth, nail infections, nausea and weight loss.

The new approval gives patients with HER2-mutated NSCLC another targeted treatment option earlier in their treatment journey. Bayer also highlighted the importance of molecular testing at the time of diagnosis to identify patients who may benefit from targeted therapies.

Lung cancer remains one of the leading causes of cancer-related deaths worldwide. HER2-mutated NSCLC represents a distinct form of the disease and can occur in people who have never smoked, creating a need for targeted treatment options.

HYRNUO was previously granted accelerated FDA approval in November 2025 for patients with locally advanced or metastatic NSCLC carrying HER2 TKD activating mutations who had already received prior systemic treatment.

With the latest decision, Bayer is expanding the use of HYRNUO into the first-line setting and bringing the targeted therapy to eligible patients earlier in the course of advanced HER2-mutated NSCLC.