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Will BDTX-1535 receive FDA approval for recurrent EGFRm NSCLC by September 30, 2025?
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FDA official announcements and press releases
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Black Diamond Therapeutics Announces Initial Phase 2 Data for BDTX-1535 in Recurrent NSCLC with 42% ORR at 200 mg
Sep 23, 2024, 11:02 AM
Black Diamond Therapeutics has announced the initial Phase 2 data for its BDTX-1535 treatment in patients with recurrent EGFRm non-small cell lung cancer (NSCLC). The data, which will be presented in a webcast at today's 8am ET call, demonstrates robust anti-tumor activity. A 200 mg daily dose has been selected for pivotal development, showing a favorable tolerability profile. Preliminary overall response rate (ORR) of 42% was observed in 19 patients with on-target resistance EGFR mutations. The treatment is effective against a broad spectrum of classical, non-classical, and C797S resistance mutations.
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