Clinical Trials Arena March 22, 2024
Breyanzi’s approval for the heavily pretreated CLL/SLL patient population brings competition to Eli Lilly’s Jaypirca.
On 14 March 2024, the US Food and Drug Administration (FDA) granted accelerated approval to Bristol Myers Squibb’s (BMS) Breyanzi, a CD19-directed chimeric antigen receptor (CAR) T-cell therapy.
The drug treats patients with relapsed or refractory (R/R) chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL), who have received at least two prior therapies, including a Bruton tyrosine kinase (BTK) inhibitor and AbbVie and Genentech’s B-cell lymphoma 2 inhibitor Venclexta. CAR T-cell therapies work by modifying a patient’s T cells to target and eliminate cancer cells through a one-time treatment with potentially long-lasting effects.
This first-ever CAR T-cell therapy with accelerated approval in CLL was...