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Cogent获得贝祖拉替尼FDA突破治疗地位
2025-10-21 05:21
- The US FDA has granted Breakthrough Therapy designation for Cogent Biosciences' bezuclastinib for NonAdvanced Systemic Mastocytosis and Smoldering Systemic Mastocytosis.
- The company plans an NDA submission for the first indication by the end of the year.
- Breakthrough Therapy status was granted based on results from the SUMMIT trial that were released in July. Data showed bezuclastinib met its primary endpoint, a highly statistically significant difference in the mean change in total symptom score (TSS) at 24 weeks versus placebo. Participants in the bezuclastinib arm demonstrated a mean reduction of 24.3 points in TSS at 24 weeks, compared to 15.4 points in the placebo cohort.
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