Tag Archives: MCL

Breyanzi Regulatory Applications for R/R FL and R/R MCL Accepted in the US and Japan

On Tuesday, January 30, BMS announced (press release) that the Breyanzi (CD19 CAR-T) sBLAs for r/r FL and r/r MCL have been accepted by the FDA with projected PDUFA dates on May 23, 2024, and May 31, 2024, respectively. Additionally, the application for Breyanzi in r/r FL has also been validated in Japan.

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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.

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Impressive Results for Breyanzi in ≥3L FL and ≥3L MCL; MB-106 Demonstrates Excellent Efficacy and Safety in R/R FL

On Saturday, June 17, BMS presented results from Breyanzi’s (CD19 CAR-T) Ph2 TRANSCEND FL trial in r/r FL patients and a primary analysis from the MCL cohort of the Ph1 TRANSCEND NHL 001 trial at ICML 2023. Moreover, Mustang Bio presented data from the FL cohort dosed with MB-106 (CD20 CAR-T) in the single-center Ph1/2 trial that led to the initiation of a registrational Ph1/2 trial for the treatment of r/r B-NHL or CLL in the same conference. Below, Celltelligence provides insights on how Breyanzi’s results compare to its key competitor CD19 CAR-Ts in ≥3L FL and ≥3L MCL, and discusses potential approval timelines for both indications in the US while analyzing which assets could rival MB-106 to become the first approved CD20 CAR-T.

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The Celltelligence Team

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Content Leads & Contributors

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.

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Initial Data from Yescarta’s Ph2 ZUMA-14 Study for R/R LBCL in Combination with Rituximab; Updated Results for Tecartus in ALL and MCL; ASCO 2022 Analysis 2

ASCO 2022 Analysis 2: Gilead (Kite) reported updated clinical data in LBCL, MCL, and adult B-ALL. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:

About The Author

The Celltelligence Team

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Content Leads & Contributors

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.

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