Juli xnumx: Breyanzi (Lisocabtagene maraleucel; liso-cel), a novel CD19-directed chimeric antigen receptor (CAR) T-cellebehandling udviklet af Bristol Myers Squibb (BMS), er blevet godkendt af US Food and Drug Administration (USFDA).
CAR-T-cellebehandling 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).
Læs også: CAR T-celleterapi i Indien
Voksne patienter med recidiverende eller refraktær (R/R) storcellet B-celle lymfom (LBCL) efter to eller flere linjer med systemisk terapi vil blive behandlet med den nye CAR T-cellebehandling. There are several types of LBCL, such as primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, follicular lymphoma grade 3B, and DLBCL not otherwise described, which can also develop from indolent lymphoma.
DLBCL-kræft er den hyppigste type non-Hodgkin-lymfom (NHL), og det er en aggressiv sygdom, hvor 73 procent af patienterne ikke reagerer på behandlingen eller vender tilbage.
Breyanzi kan derimod ikke anbefales til patienter med primært centralnervesystem lymfom, på trods af at det er en potentielt helbredende behandling.
Læs også: BIL T-cellebehandling i Kina
Breyanzi, a CAR T-cellebehandling, will be very important in clinical practice, giving people with relapsed or refractory large B-cell lymphoma the chance for a long-lasting response with a personalized treatment experience, said Samit Hirawat, chief medical officer at Bristol Myers Squibb. 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 havde en 73 procent overordnet responsrate og en 54 procent komplet respons (CR) rate i TRANSCEND NHL 001 undersøgelsen, som var den største pivotale undersøgelse i 3L+ LBCL.
BMS’ immunterapi manufacturing plant in Bothell, Washington, will produce the novel cell treatment.
CAR T-celleterapi i Indien is in the clinical trials stage, and hopefully it will be available very soon for commercial use.
