Bayer has received Breakthrough Therapy Designation in the United States and China for sevabertinib as a first-line treatment for HER2-mutant non-small cell lung cancer. The decision reflects the potential of the therapy to address high unmet medical need.
Regulatory recognition in the US and China
The US Food and Drug Administration and China’s Center for Drug Evaluation granted the designation to support the accelerated development of sevabertinib in patients with locally advanced or metastatic non-small cell lung cancer with HER2-activating mutations.
Importantly, the designation applies to first-line use, following earlier regulatory progress for the therapy in previously treated patients.
Clinical evidence supporting sevabertinib development
The regulatory decisions are supported by preliminary clinical data from cohort F of the ongoing Phase I/II SOHO-01 study. This cohort includes patients who had not previously received treatment for HER2-mutant non-small cell lung cancer.
The SOHO-01 study is evaluating the efficacy and safety of sevabertinib in patients with locally advanced or metastatic disease.
Recent FDA accelerated approval
In November 2025, sevabertinib received accelerated approval from the FDA for use in previously treated patients with advanced HER2-mutant non-small cell lung cancer. The approval was based on objective response rate and duration of response data.
The data were generated from additional SOHO-01 study cohorts involving patients who had received prior therapies, including HER2-targeted antibody-drug conjugates.
Targeted approach to HER2-mutant lung cancer
Sevabertinib is an oral, reversible small-molecule tyrosine kinase inhibitor designed to target HER2-activating mutations. As a result, the therapy is being developed as part of Bayer’s precision oncology research strategy.
Further information on Bayer’s oncology research is available via the company’s official website at bayer.com. Related coverage can be found in the Pharmaceuticals section of H2O Global News.
