Septhemba 2022: I-European Commission (EC) igunyaze abakwaKite Ukwelashwa kwe-CAR T-cell I-Tecartus® (brexucabtagene autoleucel) yokwelapha iziguli ezindala ezineminyaka engu-26 ubudala nangaphezulu ezine-B-cell precursor ebuyele emuva noma ephikisayo (r/r) i-acute lymphoblastic leukemia. I-Kite iyiNkampani yaseGileyadi (i-Nasdaq: GILD) (BONKE).
Ngokusho kukaChristi Shaw, oyi-CEO yakwaKite, “Ngale mvume, i-Tecartus iba eyokuqala nokuwukuphela kokwelashwa kwe-CAR T-cell okunconyelwe kulesi sibalo seziguli, kubhekwane nesidingo esikhulu sokwelashwa esingahlangatsheziwe.” Lokhu futhi kungokwesine ukusetshenziswa okugunyaziwe kokwelashwa kwe-Kite cell eYurophu, okufakazela izinzuzo ezizinikeza iziguli, ikakhulukazi lezo ezinezinye izindlela ezimbalwa zokwelapha.
Uhlobo oluvame kakhulu lwe KONKE, okuyisifo esiyingozi segazi, siyisandulela se-B-cell ALL. Ngonyaka, KONKE kutholakala kubantu ababalelwa ku-64,000 emhlabeni jikelele. Ngemithi yokunakekela ejwayelekile yamanje, ukusinda okuphelele kwe-median (OS) kubantu abanaBO BONKE cishe izinyanga eziyisishiyagalombili.
Ngokuka-Max S. Topp, MD, uprofesa kanye nomqondisi wesayensi ye-hematology eSibhedlela saseNyuvesi yaseWuerzburg eJalimane, “abantu abadala abaphindela emuva noma abahlubukayo BONKE bavame ukuthola ukwelashwa okuningana, okuhlanganisa ukwelapha ngamakhemikhali, ukwelapha okuhlosiwe, nokufakelwa kwe-stem cell, okudala umthwalo omkhulu. ngezinga lempilo yesiguli.” Iziguli eYurophu namuhla zizuza ekuthuthukisweni okuphawulekayo ekunakekelweni. Izimpendulo ezihlala isikhathi eside ezivela ku-Tecartus zikhomba ukuthi kungenzeka yini ukuxolelwa kwesikhathi eside kanye nesu elisha lokwelashwa.
Ucwaningo lwamazwe ngamazwe lwe-ZUMA-3 lwe-multicenter, ingalo eyodwa, ilebula evulekile, iSigaba 1/2 sokubhalisa seziguli ezikhulile (ezineminyaka engu-18 ubudala) ezibuyelwe ukugula noma eziphikayo ZONKE zinikeze imiphumela esekela ukugunyazwa. Ngokulandelelwa okumaphakathi kwezinyanga ezingama-26.8, lolu cwaningo lubonise ukuthi u-71% weziguli ezihlolwayo (n=55) zathola ukukhululwa okuphelele (CR) noma i-CR nokululama kancane kwe-hematological (CRi). Kusethi yedatha enkulu, ukusinda okuphelele okumaphakathi kwazo zonke iziguli ezithole imithamo eyinhloko (n=78) kwakungaphezu kweminyaka emibili (izinyanga ezingu-25.4), futhi kubaphenduli, cishe iminyaka emine (izinyanga ezingu-47) (iziguli ezithole i-CR noma CRi). Isikhathi esimaphakathi sokuxolelwa (DOR) phakathi kweziguli okungenzeka ukuthi ukusebenza kwazo kungahlolwa kwakuyizinyanga eziyi-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 i-cytokine release syndrome (CRS) and neurologic adverse events, which were typically adequately controlled.
