Bristol Myers Squibb announced the accelerated FDA approval of Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for treating adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior therapies, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.
This approval, based on the response rate and duration of the response in patients, marks Breyanzi as the first CAR T cell therapy option for relapsed or refractory CLL or SLL, delivered through a one-time infusion process. The therapy’s introduction is seen as a significant advancement for patients who have historically lacked a standard care for these conditions after becoming refractory or relapsing following early-line therapies.
The TRANSCEND CLL 004 study, a Phase 1/2 trial, demonstrated that 20% of patients treated with Breyanzi achieved a complete response with median duration of response not reached, alongside an established safety profile.
CLL and SLL represent common types of B-cell lymphoma, often treated initially with BTK- and BCL-2 inhibitors. Yet, patients frequently experience relapse or develop resistance to these treatments, leaving few options and resulting in poor outcomes.
This FDA approval offers hope for better tailored and effective treatments to those affected, while also emphasizing the role of CAR T cell therapies in reshaping cancer treatment strategies.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
