FDA approves Sevabertinib for HER2-mutant NSCLC

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FDA approval alert: Sevabertinib — a new targeted therapy option for treating patients with HER2-mutant NSCLC — was granted accelerated approval on November 19, 2025 by the US Food and Drug Administration (FDA). This approval benefits patients with NSCLC who have been previously treated with HER2-targeted therapies, as well as patients who have received previous treatment that did not target HER2. Learn more: https://brnw.ch/21wXIzc.

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