On May 28, 2025 Bayer reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s new drug application (NDA) and granted Priority Review designation for the investigational compound sevabertinib (BAY 2927088), an oral, small molecule, tyrosine kinase inhibitor (TKI), for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptors 2 (HER2) (ERBB2) mutations and who have received a prior systemic therapy (Press release, Bayer, MAY 28, 2025, View Source [SID1234653463]).
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"Patients with HER2-mutant NSCLC are predominantly women, may be of younger age and non-smokers. The FDA’s decision to grant Priority Review designation to our application for sevabertinib is a significant milestone that supports our ongoing efforts to develop healthcare solutions that help people living with lung cancer," said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. "If approved, sevabertinib will provide an additional treatment option for previously treated patients with advanced NSCLC harboring a HER2-activating mutation."
The NDA for sevabertinib is based on positive results from the ongoing Phase I/II SOHO-01 trial. Results from patients with advanced NSCLC harboring a HER2-activating mutation, who experienced disease progression after ≥1 systemic therapies for advanced disease and were naïve to HER2-targeted therapy.1
The FDA grants Priority Review designation for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition.2
In 2024, the FDA granted sevabertinib Breakthrough Therapy designation for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy. The Breakthrough Therapy designation was supported by preliminary clinical evidence from the SOHO-01 trial. The FDA grants Breakthrough Therapy designation for the evaluation of investigational medicines that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).3
About sevabertinib (BAY 2927088)4
Sevabertinib is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is currently being evaluated as a potential new targeted treatment option for patients with NSCLC harboring human epidermal growth factor receptors 2 (HER2) activating mutations. Sevabertinib is also being studied in patients with metastatic or unresectable solid tumors harboring HER2-activating mutations. Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that potently inhibits mutant HER2, including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR), with high selectivity for mutant vs wild-type EGFR. Investigational agent sevabertinib is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA.
About Non-Small Cell Lung Cancer (NSCLC)
Lung cancer is the leading cause of cancer-related deaths in the U.S.5 Non-Small Cell Lung Cancer (NSCLC) is the most common type of lung cancer, accounting for more than 85% of cases.4 Activating HER2 mutations are found in 2% to 4% of advanced NSCLC.6 80% of people diagnosed with NSCLC have already progressed to advanced stages, which makes it more difficult to treat.7 Patients with HER2-mutant NSCLC currently face limited targeted therapies.