MedPage Today March 15, 2024
— Lisocabtagene maraleucel (Breyanzi) nabs new indication for relapsed or refractory CLL/SLL
The FDA granted accelerated approval to lisocabtagene maraleucel (liso-cel, Breyanzi) for pretreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), drugmaker Bristol Myers Squibb announced on Thursday.
A CD19-directed cellular therapy, liso-cel becomes the first CAR-T product specifically for CLL/SLL; the one-time infusion is indicated for patients with relapsed or refractory disease following two or more prior therapies, including both a BCL-2 inhibitor such as venetoclax (Venclexta) and a Bruton’s tyrosine kinase (BTK) inhibitor such as ibrutinib (Imbruvica), acalabrutinib (Calquence), or zanubrutinib (Brukinsa).
Findings from the phase I/II TRANSCEND CLL 004 study supported the approval. Among patients with relapsed or refractory CLL/ SLL in the single-arm, open-label...
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