Bayer Wins FDA Approval for Lung Cancer Therapy

Bayer announced on 10 September 2026 that the US Food and Drug Administration granted accelerated approval for HYRNUO, also known as sevabertinib. The oral therapy is cleared as a first-line treatment for adults with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors harbor HER2 tyrosine kinase domain activating mutations. The decision followed FDA Priority Review and Breakthrough Therapy Designation.

The approval is based on results from Cohort F of the ongoing Phase I/II SOHO-01 trial involving 69 treatment-naïve patients. In this group, the objective response rate was 75%, including complete responses in 6% of patients and partial responses in 70%. Among responders, 73% maintained their response for at least six months, and 38% maintained it for at least 12 months. Continued approval remains contingent on verifying clinical benefit in the ongoing Phase III SOHO-02 trial.

HYRNUO is an oral tyrosine kinase inhibitor derived from Bayer's research alliance with the Broad Institute of MIT and Harvard. In November 2025, the drug received its initial accelerated FDA approval for patients with HER2-mutated advanced non-small cell lung cancer who had received prior systemic therapy.

In the safety evaluation of 191 patients in SOHO-01, the most common adverse reactions occurring in more than 20% of participants included diarrhea, rash, stomatitis, paronychia, nausea, and decreased weight. In the pooled safety group, diarrhea was reported in 89% of patients, and hepatotoxicity occurred in 29%.