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Blossomhill Says FDA Grants Fast Track Designation To BH-30643 For Treatment Of Adult Patients With Advanced Or Metastatic EGFR C797S-Positive NSCLC After Prior Treatment With Third-Gen EGFR Tyrosine Kinase Inhibitor

Benzinga·08/18/2026 11:02:05
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BlossomHill Therapeutics, Inc. (NASDAQ:BLSM), a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to design and develop innovative small molecule medicines for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BH-30643 for the treatment of adult patients with advanced or metastatic epidermal growth factor receptor (EGFR) C797S-positive non-small cell lung cancer (NSCLC) after prior treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI). BH-30643 is being evaluated in SOLARA, a global Phase 1/2, first-in-human clinical trial enrolling patients at more than 40 sites in 10 countries.