July 2021: Breyanzi (Lisocabtagene maraleucel; liso-cel), a novel CD19-directed chimeric antigen receptor (CAR) T cell treatment developed by Bristol Myers Squibb (BMS), has been approved by the US Food and Drug Administration (USFDA).
CAR-T cell therapy is a sort of immunotherapy that works by altering a person’s T cells to recognize and destroy cancer cells.
Breyanzi, a novel CD19-directed chimeric antigen receptor (CAR) T cell treatment developed by Bristol Myers Squibb (BMS), has been approved by the US Food and Drug Administration (USFDA) (Lisocabtagene maraleucel; liso-cel).
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Adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy will be treated with the new CAR T cell therapy. DLBCL not otherwise described (including DLBCL emerging from indolent lymphoma), primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and follicular lymphoma grade 3B are all classified as LBCL.
DLBCL cancer is the most frequent type of non-Hodgkin lymphoma (NHL), and it is an aggressive illness in which 73 percent of patients do not respond to treatment or recur.
Breyanzi, on the other hand, is not recommended for patients with primary central nervous system lymphoma, despite the fact that it is a potentially curative treatment.
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“Breyanzi, a CAR T cell therapy, will play a crucial role in clinical practice, enabling people living with relapsed or refractory large B-cell lymphoma the possibility for a sustained response with a tailored treatment experience,” said Bristol Myers Squibb chief medical officer Samit Hirawat. Our unwavering commitment to advancing cell therapy research, providing breakthrough medicines, and supporting patients at every step of their treatment journey is reflected in the FDA approval.”
Breyanzi had a 73 percent overall response rate and a 54 percent complete response (CR) rate in the TRANSCEND NHL 001 study, which was the largest pivotal trial in 3L+ LBCL.
BMS’ immunotherapy manufacturing plant in Bothell, Washington will produce the novel cell treatment.
CAR T-Cell therapy in India is at clinical trials stage and hopefully it will be available very soon for commercial use.