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Lisocabtagene maraleucel granted FDA approval for the treatment of R/R CLL/SLL
On March 14, 2024, the U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adult patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.1 Lisocabtagene maraluecel was previously granted priority review for this indication.
This approval is based on results from the phase I/II TRANSCEND CLL 004 trial (NCT03331198), which were previously covered by the Lymphoma Hub.1 Briefly, the complete remission and overall response rates were 20% and 45%, respectively. The median duration of response among patients who achieved a complete remission was not reached. Lisocabtagene maraluecel comes with a boxed warning for cytokine release syndrome, neurologic toxicities, and secondary hematologic malignancies.1
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Which of the following would most increase your confidence in referring patients with R/R large B-cell lymphoma for CAR T-cell therapy?