The FDA granted accelerated approval of lisocabtagene maraleucel (Breyanzi, Bristol Myers Squibb), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adult patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton’s tyrosine kinase inhibitor and B-cell lymphoma 2 inhibitor.
The phase 1/2, open-label, single-arm TRANSCEND CLL 004 study
MARCH 19, 2024