FDA grants accelerated approval for Bayer lung cancer drug sevabertinib in first-line HER2-mutant NSCLC

Reuters2026/09/09 18:23

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FDA granted accelerated approval for Bayer’s sevabertinib as first-line therapy in adults with advanced HER2-mutant non-squamous NSCLC.
Clearance covers tumors with HER2/ERBB2 TKD activating mutations identified by an FDA-authorized test.
Decision relied on SOHO-01 data in 69 treatment-naïve patients, showing a 75% objective response rate.
Ongoing Phase III SOHO-02 trial could determine continued approval.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Bayer AG published the original content used to generate this news brief on September 09, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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FDA grants accelerated approval for Bayer lung cancer drug sevabertinib in first-line HER2-mutant NSCLC

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