Julayi 2021: Breyanzi (Lisocabtagene maraleucel; liso-cel), i-CD19-directed chimeric antigen receptor inoveli (CAR) Ukwelashwa kwe-T cell akhiwa I-Bristol Myers squibb (BMS), igunyazwe yi-US Food and Drug Administration (USFDA).
Ukwelashwa kwamaseli e-CAR-T iwuhlobo lwe-immunotherapy olusebenza ngokushintsha ama-T cell womuntu ukuze abone futhi abhubhise amangqamuzana omdlavuza.
I-Breyanzi, inoveli yokwelashwa kwe-CD19-directed chimeric antigen receptor (CAR) T cell eyakhiwe nguBristol Myers Squibb (BMS), kuvunywe Ukuphathwa Kwezokudla Nezidakamizwa e-US (USFDA) (Lisocabtagene maraleucel; liso-cel).
Funda futhi: Ukwelashwa kwe-CAR T-Cell eNdiya
Iziguli ezikhulile ezine-B-cell lymphoma (LBCL) enkulu ebuyele emuva noma e-refractory (R/R) ngemva kwemigqa emibili noma ngaphezulu yokwelashwa kwe-systemic zizophathwa ngendlela entsha. Ukwelashwa kwamaseli e-CAR T. Kunezinhlobo eziningana ze-LBCL, njenge-primary mediastinal big-cell lymphoma, i-high-grade B-cell lymphoma, i-follicular lymphoma grade 3B, kanye ne-DLBCL engachazwanga ngenye indlela, engase futhi ithuthuke ku-indolent lymphoma.
Umdlavuza we-DLBCL uwuhlobo oluvame kakhulu lwe-non-Hodgkin lymphoma (NHL), futhi yisifo esihlaselayo lapho amaphesenti angu-73 eziguli angaphenduli ekwelashweni noma aphinde avele.
I-Breyanzi, ngakolunye uhlangothi, ayinconywa ezigulini ezine-primary central central nervous system lymphoma, naphezu kweqiniso lokuthi iyindlela yokwelapha engaba namandla.
Futhi funda: Ukwelashwa kwe-CAR T-Cell eChina
Breyanzi, a Ukwelashwa kwamaseli e-CAR T, 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.”
UBreyanzi ube nenani lokuphendula eliphelele elingamaphesenti angu-73 kanye nesilinganiso sokuphendula esiphelele samaphesenti angu-54 (CR) ocwaningweni lwe-TRANSCEND NHL 001, okwakuyisivivinyo esikhulu kunazo zonke ku-3L+ LBCL.
BMS’ immunotherapy manufacturing plant in Bothell, Washington, will produce the novel cell treatment.
Ukwelashwa kwe-CAR T-Cell eNdiya isesigabeni sezivivinyo zemitholampilo, futhi ngethemba ukuthi izotholakala maduze ukuze isetshenziselwe ukuthengisa.
