BERLIN — September 9, 2026
Bayer announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for sevabertinib as a first-line treatment option for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors carry activating HER2/ERBB2 tyrosine kinase domain (TKD) mutations detected by an FDA-authorized test. The approval follows FDA Priority Review and Breakthrough Therapy Designation and expands sevabertinib’s role in a patient population with limited treatment options and poor prognosis. The oral, reversible small-molecule tyrosine kinase inhibitor is designed to selectively target mutant HER2. The first-line approval is based on results from the ongoing Phase I/II SOHO-01 trial, while continued approval may depend on confirmation of clinical benefit from the ongoing Phase III SOHO-02 study. The regulatory milestone strengthens Bayer’s precision oncology strategy and expands access to targeted treatment for a genetically defined lung cancer population.
SOHO-01 Data Demonstrate High Response Rates
The FDA’s accelerated approval is supported by objective response rate (ORR) and duration of response (DOR) data from 69 treatment-naïve patients enrolled in SOHO-01. In this cohort, sevabertinib produced an ORR of 75%, including complete responses in 6% of patients and partial responses in 70%. Among responders, 73% maintained their response for at least six months, supporting the potential durability of treatment activity. The safety profile was reported to be consistent with previous clinical findings. SOHO-01 is evaluating sevabertinib in patients with locally advanced or metastatic HER2-mutant NSCLC and has supported development across different treatment settings. Bayer is now evaluating the therapy in the confirmatory Phase III SOHO-02 trial, which compares sevabertinib with standard of care in treatment-naïve patients with advanced HER2-mutant NSCLC. Confirmation of clinical benefit in this study will be important for maintaining the accelerated approval.
Sevabertinib Expands Global Precision Oncology Reach
The U.S. first-line approval builds on an expanding international regulatory footprint for sevabertinib. Bayer previously received FDA accelerated approval in November 2025 for patients with previously treated advanced HER2-mutant NSCLC based on SOHO-01 data. The therapy has also received approval in China for previously treated unresectable, locally advanced or metastatic NSCLC with HER2 activating mutations, while Japanese authorities have approved sevabertinib as a targeted therapy that can be used across treatment lines, including first-line treatment. In China, the Center for Drug Evaluation has granted Breakthrough Therapy Designation for both previously treated disease and first-line development. Sevabertinib inhibits mutant HER2, including exon 20 insertions and HER2 point mutations, by blocking tyrosine kinase signaling involved in cancer-cell growth. The program originated from Bayer’s strategic research collaboration with the Broad Institute of MIT and Harvard, highlighting the company’s strategy of combining external scientific partnerships with internally driven precision oncology development.
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Bayer Builds Broader HER2-Directed Development Strategy
Bayer is continuing to expand sevabertinib beyond first-line HER2-mutant NSCLC through multiple clinical programs. In addition to SOHO-01 and the Phase III SOHO-02 confirmatory trial, the company is evaluating sevabertinib in the panSOHO Phase I/II study in patients with metastatic or unresectable solid tumors carrying HER2 activating mutations, excluding advanced NSCLC. The expansion reflects the potential to apply HER2-directed precision medicine across genetically defined tumor populations. HER2 mutations occur in approximately 2% to 4% of patients with advanced NSCLC, creating a relatively small but clinically important molecular subgroup with significant unmet need. The FDA decision therefore represents both a treatment milestone and a validation of Bayer’s targeted oncology approach. With accelerated approval now extending sevabertinib into the first-line setting, ongoing Phase III confirmation and broader solid-tumor development will determine the therapy’s long-term role within Bayer’s global precision oncology portfolio.
Source: Bayer, press release
