Drug Topics March 15, 2024
The approval was based on data from the phase 1/2 TRANSCEND CLL 004 study, in which the CAR T cell therapy demonstrated statistically significant complete response rates.
Lisocabtagene maraleucel (Breyanzi; liso-cel) has received accelerated approval from the FDA for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients who have received at least 2 prior lines of therapy, Bristol Myers Squibb announced in a release.1
The approval was based on data from the phase 1/2 TRANSCEND CLL 004 (NCT03331198) study, in which lisocabtagene maraleucel demonstrated statistically significant complete response rates (CR) in a primary efficacy analysis, with no disease progression or deaths among the patients who achieved CR.
“CAR T...
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