Yuli 2021: Breyanzi (Lisocabtagene maraleucel; liso-cel), wani labari CD19-directed chimeric antigen receptor (CAR) Maganin T cell ci gaba da Bristol Myers Squibb (BMS), Hukumar Abinci da Magunguna ta Amurka (USFDA) ta amince da ita.
CAR-T cell far wani nau'i ne na rigakafi wanda ke aiki ta hanyar canza ƙwayoyin T na mutum don ganewa da lalata ƙwayoyin cutar kansa.
Breyanzi, wani labari na CD19-directed chimeric antigen receptor (CAR) T cell magani wanda Bristol Myers Squibb (BMS) ya haɓaka, ya sami amincewa da shi. Hukumar Abinci da Magunguna ta Amurka (USFDA) (Lisocabtagene maraleucel; liso-cel).
Hakanan karanta: CAR T-Cell far a Indiya
Marasa lafiya marasa lafiya tare da koma baya ko rashi (R/R) babban lymphoma B-cell (LBCL) bayan layuka biyu ko fiye na tsarin jinya za a bi da su tare da sabon CAR T cell far. Akwai nau'ikan LBCL da yawa, irin su na farko na tsakiya na babban lymphoma B-cell, lymphoma mai girma B-cell lymphoma, follicular lymphoma grade 3B, da DLBCL ba a bayyana ba, wanda kuma zai iya tasowa daga lymphoma maras kyau.
Ciwon daji na DLBCL shine mafi yawan nau'in lymphoma ba Hodgkin (NHL), kuma cuta ce mai ƙarfi wanda kashi 73 cikin dari na marasa lafiya basa amsa magani ko sake dawowa.
Breyanzi, a gefe guda, ba a ba da shawarar ga marasa lafiya da keɓaɓɓun tsarin jijiyoyin jini na lymphoma, duk da cewa yana da yuwuwar magani.
Har ila yau karanta: CAR T-Cell far a China
Breyanzi, a CAR T cell far, 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 yana da kashi 73 na jimlar amsa duka da kashi 54 cikin ɗari na cikakken amsa (CR) a cikin binciken TRANSCEND NHL 001, wanda shine babban gwaji mafi mahimmanci a cikin 3L+ LBCL.
BMS’ immunotherapy manufacturing plant in Bothell, Washington, will produce the novel cell treatment.
CAR T-Cell far a Indiya yana cikin matakin gwaji na asibiti, kuma da fatan za a samu nan ba da jimawa ba don amfanin kasuwanci.
