FDA Grants Priority Review to Bayer's NSCLC Drug Sevabertinib

Key Highlights:

• FDA Grants Priority Review for Bayer’s sevabertinib to treat HER2-mutant NSCLC.
• Breakthrough Therapy designation accelerates development based on promising SOHO-01 trial results.
• Sevabertinib aims to fill a significant unmet need in patients with limited treatment options.

Bayer announced that its investigational drug, sevabertinib, has been granted Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) bearing activating HER2 (ERBB2) mutations, following prior systemic therapy. Sevabertinib is an oral small molecule tyrosine kinase inhibitor (TKI) designed to treat HER2-driven cancers.

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Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer said, “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 validates both the unmet need and the potential for sevabertinib to fulfill that need.”

Priority Review is supported by favorable data from the ongoing Phase I/II SOHO-01 trial, which is assessing sevabertinib in NSCLC patients with HER2-activating mutations who had progressed following at least one prior systemic therapy and were naïve to HER2-targeted TKIs. Sevabertinib has also received Breakthrough Therapy designation to facilitate expedited development for drugs which demonstrate clinically meaningful improvement to the available options.

Sevabertinib remains an investigational therapy and has not yet been approved by any health authority. It continues to be studied as a potential precision treatment for HER2-mutant NSCLC.