Julie 2021: Breyanzi (Lisocabtagene maraleucel; liso-cel), a novel CD19-directed chimeric antigen receptor (CAR) T -selbehandeling ontwikkel deur Bristol Myers Squibb (BMS), is goedgekeur deur die Amerikaanse Food and Drug Administration (USFDA).
CAR-T-selterapie 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 Amerikaanse voedsel- en dwelmadministrasie (USFDA) (Lisocabtagene maraleucel; liso-cel).
Lees ook: CAR T-selterapie in Indië
Volwasse pasiënte met teruggeval of refraktêre (R/R) groot B-sel limfoom (LBCL) na twee of meer reëls van sistemiese terapie sal behandel word met die nuwe CAR T-selterapie. 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 kanker is die mees algemene tipe nie-Hodgkin limfoom (NHL), en dit is 'n aggressiewe siekte waarin 73 persent van pasiënte nie reageer op behandeling of herhaal nie.
Breyanzi, aan die ander kant, word nie aanbeveel vir pasiënte met primêre sentrale senuweestelsel limfoom nie, ondanks die feit dat dit 'n potensieel genesende behandeling is.
Lees ook: CAR T-selterapie in China
Breyanzi, a CAR T-selterapie, 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 het 'n algehele reaksietempo van 73 persent en 'n 54 persent volledige respons (CR) in die TRANSCEND NHL 001 -studie, wat die grootste toets in 3L+ LBCL was.
BMS’ immunotherapie manufacturing plant in Bothell, Washington, will produce the novel cell treatment.
CAR T-selterapie in Indië is in the clinical trials stage, and hopefully it will be available very soon for commercial use.