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BMS’ Breyanzi Receives the US FDA’s Approval for the Treatment of R/R Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

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BMS’ Breyanzi Receives the US FDA’s Approval for the Treatment of R/R Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

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  • BMS’ Breyanzi (lisocabtagene maraleucel; liso-cel) has received accelerated approval from the US FDA to treat r/r chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) patients who have previously received BTK inhibitor & a BCL-2 inhibitor
  • The approval was based on the P-I/II (TRANSCEND CLL 004) dose escalation & expansion trial assessing the safety, efficacy & RP2D of Breyanzi for treating r/r CLL/SLL
  • The results demonstrated a CR rate of 20%, a high MRD negativity rate of 100% in blood & 92.3% in bone marrow with mDoR not reached among patients achieving CR. ORR was 45% & mDoR was 35.3mos. in all of them

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Related News:- BMS Reports the Acceptance of sBLA by the US FDA and Japan MHLW for Breyanzi to Treat Follicular Lymphoma (FL) and Mantle Cell Lymphoma (MCL)

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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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