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Autologous, CAR-T, CD19

November 10, 2023

Breyanzi sBLA for R/R CLL/SLL Receives FDA Priority Review

Here is a brief preview of this blast: On Thursday, November 9, BMS announced (press release) FDA accepted the sBLA for the expansion of Breyanzi’s (CD19 CAR-T) label to include r/r chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The company confirmed that the FDA has granted Priority Review to the application and set a PDUFA date of March 14, 2024. Below, Celltelligence provides insights on the results of the Ph1/2 TRANSCEND CLL 004 trial supporting the application while discussing BMS’s strategy for the hypothetical use of Breyanzi in 2L CLL/SLL.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.