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BMS’ Breyanzi (lisocabtagene maraleucel) Receives the US FDA’s Approval for the Treatment of Large B-cell Lymphoma

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BMS’ Breyanzi (lisocabtagene maraleucel) Receives the US FDA’s Approval for the Treatment of Large B-cell Lymphoma

BMS’ Breyanzi (lisocabtagene maraleucel) Receives the US FDA’s Approval for the Treatment of Large B-cell Lymphoma

Shots:

  • The approval was based on the P-III (TRANSFORM) study evaluating Breyanzi vs standard therapy regimens in adults with LBCL that was primary refractory or relapsed within 12mos. after 1L therapy
  • The results showed improvements in EFS, CR & PFS; m-EFS (10.1mos. vs 2.3mos.); CR (66% vs 39%) with a median duration of CR (not reached); m-PFS (14.8mos. vs 5.7mos.), 97% received treatment over 47% who completed high-dose CT & autologous HSCT, well-established safety profile
  • The approval was also based on the P-II (PILOT) study which showed deep & durable responses with ORR (80%), CR rate (54%) with a median time to CR of 1mos., m-DoR (11.2mos.) while m-DoR was not reached in those patients who achieved a CR

Ref:  Globenewswire| Image: BMS

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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