Sebtembar 2022: Komishanka Yurub (EC) ayaa oggolaaday Kite's CAR T-cell daaweynta Tecartus® (brexucabtagene autoleucel) ee daawaynta bukaanada qaangaarka ah ee da'doodu tahay 26 sano iyo ka weyn ee leh soo noqoshada unugyada B-cell lymphoblastic leukemia ba'an. Kite waa shirkad Gilecaad ah (Nasdaq: GILD) (Dhammaan).
Sida laga soo xigtay Christi Shaw, Maamulaha Kite, "Oggolaanshahan, Tecartus wuxuu noqonayaa daawaynta ugu horreysa oo kaliya ee CAR T-cell ee lagula taliyay dadka bukaanka ah, wax ka qabashada baahi caafimaad oo weyn oo aan la daboolin." Tani sidoo kale waa isticmaalka afraad ee daawaynta unugga Kite ee Yurub, taas oo caddaynaysa faa'iidooyinka ay siiyaan bukaannada, gaar ahaan kuwa leh dhowr nooc oo kale oo daaweyneed ah.
Nooca ugu badan ee ALL, kaas oo ah dhiig-xumo xoog leh, waa hor-u-dhaca unugyada-B-unugga oo dhan. Sannadkii, DHAMMAAN waxaa lagu baaro ilaa 64,000 oo qof oo adduunka oo dhan ah. Dawooyinka daryeelka caadiga ah ee hadda jira, badbaadada guud ee dhexdhexaadka ah (OS) ee shakhsiyaadka DHAMMAAN leh waa qiyaastii siddeed bilood.
Sida laga soo xigtay Max S. Topp, MD, borofisar iyo agaasimaha hematology ee Isbitaalka Jaamacadda Wuerzburg ee Jarmalka, "dadka qaan-gaarka ah ee soo noqnoqda ama dib-u-celinta DHAMMAAN waxay si joogta ah u maraan daweyno badan, oo ay ku jiraan daaweynta kemotherabi, daawaynta la beegsanayo, iyo tallaalka unugyada stem, abuurista culeys weyn. oo ku saabsan tayada nolosha bukaanka." Bukaan-socodka Yurub maanta waxay ka faa'iideysteen horumar weyn oo xagga daryeelka ah. Jawaabaha waara ee Tecartus waxay tilmaamayaan suurtogalnimada cafiska muddada-dheer iyo istaraatiijiyad daaweyn cusub.
Xarunta caalamiga ah ee ZUMA-3, hal-cudud, sumad furan, Wajiga 1/2 ee diiwaan gelinta daraasadda bukaannada qaangaarka ah (18 jir) ee soo noqnoqday ama diiddan DHAMMAAN waxay bixiyeen natiijooyinka taageeray oggolaanshaha. Dabagalka dhexdhexaadka ah ee bilaha 26.8, daraasaddan ayaa muujisay in 71% bukaannada la qiimeeyo (n=55) ay la kulmeen cafis dhammaystiran (CR) ama CR oo leh qayb ka mid ah soo kabashada dhiigbaxa (CRi). Xogta ballaaran, badbaadada guud ee dhexdhexaadka ah ee dhammaan bukaannada helay qiyaasaha muhiimka ah (n=78) waxay ka badnaayeen laba sano (25.4 bilood), iyo jawaab-bixiyeyaasha, waxay ku dhowdahay afar sano (47 bilood) (bukaannada gaaray CR) ama CRi). Muddada dhexdhexaadinta cafiska (DOR) ee bukaannada waxtarkooda la qiimeyn karo waxay ahayd 18.6 bilood.
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 sii daayo syndrome (CRS) and neurologic adverse events, which were typically adequately controlled.
