Bayer US FDA Accepts Priority Review for Sevabertinib in HER2-Mutant NSCLC
Thursday, May 29, 2025
Bayer has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for sevabertinib (BAY 2927088) and granted the investigational treatment Priority Review status.
Sevabertinib is a reversible, oral TKI that selectively targets mutant forms of HER2, including exon 20 insertions and point mutations, as well as mutant EGFR, while sparing the wild-type EGFR. It is currently being studied for its potential in NSCLC and other solid tumours with HER2-activating mutations. The compound stems from a strategic research collaboration between Bayer and the Broad Institute of MIT and Harvard.
Lung cancer remains the leading cause of cancer-related deaths in the United States, with NSCLC accounting for over 85 percent of all cases. HER2 mutations occur in approximately 2 to 4 percent of advanced NSCLC cases. Most patients are diagnosed at advanced stages, where treatment choices are limited, and there are currently few targeted therapies available for HER2-mutant NSCLC.
Sevabertinib is an oral, small molecule tyrosine kinase inhibitor (TKI) under development for adults with advanced non-small cell lung cancer (NSCLC) harbouring HER2 (ERBB2) activating mutations, following prior systemic therapy.
The submission is supported by positive findings from the ongoing Phase I/II SOHO-01 trial. This study includes patients with HER2-mutant NSCLC who had previously received at least one systemic treatment and had not been treated with HER2-targeted therapies.
Priority Review is reserved for drug candidates that could offer major advancements in the treatment or diagnosis of serious conditions. Earlier in 2024, sevabertinib also received Breakthrough Therapy designation from the FDA, based on preliminary evidence suggesting the treatment may offer significant clinical benefit compared to existing options.
Source: bayer.com
