Bayer Gets FDA Accelerated Approval for Lung Cancer Treatment
By Katherine Hamilton
Bayer received accelerated approval from the Food and Drug Administration for its treatment of non-small cell lung cancer.
The FDA approved sevabertinib as a first-line treatment for patients with advanced HER2-mutant lung cancer, following a priority review and breakthrough therapy designations, the company said Wednesday.
The approval is based on an ongoing Phase 1/2 SOHO-01 trial evaluating the efficacy and safety of sevabertinib.
Objective response rate was 75%, with complete responses in 6% of the patients. About 73% of responders maintained a response for at least six months, Bayer said.
Continued approval may be contingent on verification and description of clinical benefit in the ongoing Phase III confirmatory trial.
Sevabertinib was already approved in November 2025 as a treatment for patients with the same illness who had already been treated.
Write to Katherine Hamilton at katherine.hamilton@wsj.com
(END) Dow Jones Newswires
September 09, 2026 15:10 ET (19:10 GMT)
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