PRINCETON, N.J. - Bristol Myers Squibb (NYSE: NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy. This approval allows the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have undergone at least two prior therapies, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.
This indication is based on response rate and duration of response and may be contingent upon verification and description of clinical benefits in confirmatory trials. Breyanzi, which is administered as a one-time infusion, has shown a 20% complete response rate in the TRANSCEND CLL 004 study, a pivotal multicenter trial evaluating CAR T cell therapy in patients with relapsed or refractory CLL or SLL. The median duration of the complete response has not yet been reached, indicating potential long-term benefits.
The study, which included 89 patients treated with Breyanzi, reported occurrences of cytokine release syndrome (CRS) and neurologic events (NEs), mostly low grade. CRS occurred in 83% of patients with 9% experiencing Grade 3 CRS, while NEs were reported in 46% of patients, with Grade 3 NEs in 20% of patients and one case of Grade 4 NE.
The approval of Breyanzi marks a significant advancement for patients with CLL or SLL, providing a personalized treatment option that could result in complete and potentially lasting remissions after failing previous therapies. CLL and SLL are considered incurable diseases with limited treatment options in the relapsed setting, and complete responses are generally associated with improved long-term outcomes.
Bristol Myers Squibb offers support programs and resources to address patient and caregiver needs and provides access to therapies, including Breyanzi. The company also provides a digital service platform, Cell Therapy 360, to optimize access to information and patient support.
Breyanzi is also approved in the U.S., Japan, and Europe for the second-line treatment of relapsed or refractory large B-cell lymphoma (LBCL), and in Japan, Europe, Switzerland, and Canada for relapsed and refractory LBCL after two or more lines of systemic therapy. The clinical development program for Breyanzi includes studies in other types of lymphoma.
This news is based on a press release statement from Bristol Myers Squibb.
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