BERLIN, Germany, May 18, 2026
Bayer has announced that the U.S. Food and Drug Administration (FDA) granted Priority Review designation for sevabertinib as a first-line treatment for adult patients with HER2-mutant non-small cell lung cancer (NSCLC). The regulatory milestone highlights the therapy’s potential to address a major unmet need in precision oncology and further strengthens Bayer’s expanding targeted cancer therapy portfolio.
The FDA Priority Review applies to therapies that may provide significant improvements in safety or effectiveness for serious diseases compared to currently available treatments. Bayer stated that the submission specifically targets patients with locally advanced or metastatic NSCLC whose tumors carry HER2 (ERBB2) tyrosine kinase domain activating mutations, a genetically defined subgroup of lung cancer patients with limited therapeutic options.
The regulatory application for first-line use is based on encouraging results from the ongoing Phase I/II SOHO-01 clinical trial, which is evaluating the efficacy and safety of sevabertinib in patients with advanced HER2-mutant NSCLC. Bayer executives described the FDA decision as an important advancement for precision oncology and emphasized the urgent need for more effective and better tolerated therapies capable of improving survival outcomes earlier in the treatment course.
Precision Oncology Focus Drives Lung Cancer Innovation
Non-small cell lung cancer remains the most common form of lung cancer globally, accounting for more than 85% of all lung cancer cases. HER2 activating mutations occur in approximately 2% to 4% of advanced NSCLC patients, representing a relatively small but clinically significant patient population with historically limited targeted treatment options.
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Industry experts note that nearly 80% of NSCLC patients are diagnosed at advanced stages of disease, making effective targeted therapies critically important for improving long-term patient outcomes. HER2-mutant NSCLC is often associated with aggressive disease progression and poor prognosis, increasing demand for therapies capable of delivering durable clinical benefit with manageable safety profiles.
Sevabertinib is an oral, reversible, small-molecule tyrosine kinase inhibitor (TKI) designed to selectively inhibit mutant HER2 receptors, including HER2 exon 20 insertions and HER2 point mutations, while also targeting epidermal growth factor receptor (EGFR) pathways. The therapy was engineered to provide high selectivity for mutant receptors while potentially reducing toxicity associated with wild-type EGFR inhibition.
Researchers believe reversible TKIs may offer important clinical advantages because they allow temporary and more controlled target inhibition, potentially minimizing long-term adverse effects compared with irreversible kinase inhibitors commonly used in oncology treatment.
Previous FDA Approval Strengthens Clinical Momentum
The latest Priority Review follows the FDA’s accelerated approval of sevabertinib under the brand name Hyrnuo™ in November 2025 for previously treated advanced HER2-mutant NSCLC patients. That approval was based on objective response rate and duration-of-response findings from earlier cohorts within the SOHO-01 trial.
In addition to U.S. regulatory progress, sevabertinib recently received approval from China’s National Medical Products Administration (NMPA) for adults with unresectable or metastatic HER2-mutant NSCLC who had received one prior systemic therapy.
Bayer also confirmed that sevabertinib previously received Breakthrough Therapy Designation from both the FDA and China’s Center for Drug Evaluation in December 2025, further accelerating global development efforts for the therapy.
Bayer Expands Next-Generation Oncology Pipeline
Sevabertinib was developed through Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard and forms part of the company’s broader commitment to precision oncology and targeted cancer medicine innovation. Bayer is continuing to expand clinical development through the Phase III SOHO-02 trial and the broader panSOHO study, evaluating sevabertinib across multiple HER2-activating solid tumors.
The company’s oncology strategy increasingly focuses on next-generation targeted therapies, tumor intrinsic pathways, immuno-oncology, and precision medicine platforms designed to improve outcomes for genetically defined cancer populations.
As global oncology drug development continues shifting toward biomarker-driven therapies, the FDA Priority Review for sevabertinib underscores growing regulatory support for precision-targeted treatments capable of addressing critical unmet needs in advanced lung cancer care.
Source: Bayer press release
