Sept 2022: European Commission (EC) yakabvumidza Kite's CAR T-cell kurapa Tecartus® (brexucabtagene autoleucel) yekurapa kwevarwere vakuru vane makore makumi maviri nematanhatu ezera uye vakuru vane kudzoka kana kuramba (r/r) B-cell precursor. acute lymphoblastic leukemia. Kite iGiriyedhi Kambani (Nasdaq: GILD) (VOSE).
Sekureva kwaChristi Shaw, CEO weKite, "Nemvumo iyi, Tecartus inova yekutanga uye yega CAR T-cell therapy inokurudzirwa kuhuwandu hwevarwere, ichigadzirisa chinodikanwa chikuru chekurapa." Iyi zvakare ndiyo yechina yakatenderwa kushandiswa kweKite cell therapy muEurope, zvichiratidza zvakanakira zvavanopa kuvarwere, kunyanya avo vane dzimwe nzira shoma dzekurapa.
Rudzi rwakanyanya kupararira rwe ALL, inova hutsinye hweropa, iB-cell precursor ALL. Pagore, ZVESE zvinoonekwa muvanhu vanosvika 64,000 pasi rose. Nemishonga yazvino-yekutarisira, iyo yepakati pese kupona (OS) kune vanhu vane ZVESE ingangoita mwedzi misere.
Maererano naMax S. Topp, MD, purofesa uye mutungamiriri wehematology paUniversity Hospital yeWuerzburg kuGermany, “vanhu vakuru vane kudzokazve kana kuti kuramba VOSE vanowanzorapwa kakawanda, kusanganisira chemotherapy, kurapwa kwakananga, uye stem cell transplant, zvichiita mutoro wakakura. pamusoro pehupenyu hwemurwere.” Varwere muEurope nhasi vanobatsirwa nekuvandudzwa kwakakosha mukutarisira. Mhinduro dzakasimba kubva kuTecartus dzinonongedza mukana wekuregererwa kwenguva refu uye nzira itsva yekurapa.
ZUMA-3 international multicenter, single-arm, open-label, registration Phase 1/2 yevarwere vakura (18 years old) vane kudzoka zvekare kana kuramba ALL vakapa mhedzisiro yaitsigira mvumo. Nekutevera kwepakati kwemwedzi ye26.8, chidzidzo ichi chakaratidza kuti 71% yevarwere vanoongororwa (n = 55) vakawana kuregererwa kwakakwana (CR) kana CR ine chikamu chehematological recovery (CRi). Mune yakakura data set, iyo yepakati pese kupona kwevarwere vese vakagamuchira akakosha madosi (n = 78) yaive makore anopfuura maviri (25.4 mwedzi), uye kune vakapindura, yaive makore mana (47 mwedzi) (varwere vakawana CR. kana CRi). Iyo yepakati nguva yekuregererwa (DOR) pakati pevarwere vane kushanda kwavo kwaigona kuongororwa yaive mwedzi 18.6.
The safety outcomes among the patients given Tecartus at the target dose (n=100) were consistent with the drug’s known safety profile. 25% and 32% of patients, respectively, experienced grade 3 or higher cytokine release syndrome (CRS) and neurologic adverse events, which were typically adequately controlled.
