Replies to post #1121 on Bristol Myers Squibb (BMY)

[DewDiligence]

BMY’s Breyanzi meets primary endpoint in rrCLL/SLL single-arm trial:

https://finance.yahoo.com/news/bristol-myers-squibb-announces-transcend-115900140.html

Bristol Myers Squibb today announced topline results from TRANSCEND CLL 004, a Phase 1/2, open-label, single-arm, multicenter study evaluating Breyanzi (lisocabtagene maraleucel) in adults with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Results from TRANSCEND CLL 004 showed the study met the primary endpoint of complete response rate compared to historical control in the prespecified subset of patients with R/R CLL that was refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor.

The trial listing is at:
https://www.clinicaltrials.gov/ct2/show/NCT03331198

[DewDiligence]

CHMP approves Breyanzi in second-line LBCL:

https://www.businesswire.com/news/home/20230330005697/en

FDA approval in this indication came in Jun 2022 (#msg-169240243).