Maarso 2022: Ka dib afar ama in ka badan oo daawaynta hore ah, oo ay ku jiraan proteasome inhibitor (PI), wakiilka immunomodulatory (IMiD), iyo anti-CD38 monoclonal antibody, Maamulka Cuntada iyo Dawooyinka ayaa ansixiyay ciltacabtagene autoleucel (CARVYKTI, Janssen Biotech, Inc.) loogu talagalay daawaynta bukaanada qaangaarka ah ee leh labakaclaynta ama dib u soo noqoshada myeloma badan.
Ciltacabtagene autoleucel waa autologous chimeric antigen reseptor CAR T-cell daawaynta kaas oo beegsanaya B-cell maturation antigen (BCMA). Qiyaas kasta waxa lagu habeeyey unugyada T-ka ee bukaanka, kuwaas oo la goostay, hidde ahaan wax laga beddelay, ka dibna dib loogu soo celiyay bukaanka.
CARTITUDE-1 (NCT03548207) was an open label, multicenter tijaabada caafimaadka that looked at the safety and efficacy of ciltacabtagene autoleucel in 97 patients with relapsed or refractory Meelo badan who had received at least three prior lines of therapy, including a PI, an IMiD, and an anti-CD38 monoclonal antibody, and who had disease progression on or after the last chemotherapy regimen Patients were given 0.51.0106 CAR-positive viable T cells per kg body weight of ciltacabtagene autoleucel. Efficacy was determined by an Independent Review committee utilising the International Myeloma Working Group Uniform Response Criteria for Multiple Myeloma to assess overall response rate (ORR) and duration of response (DOR). The ORR was 97.9% (95 percent confidence interval: 92.7 percent, 99.7%). The median duration of response (DOR) was 21.8 months (95 percent CI: 21.8, NE) among the 95 patients who responded, with a median follow-up period of 18 months.
The CARVYKTI label includes a boxed warning for cytokine sii daayo syndrome (CRS), hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), Parkinsonism and Guillain-Barré syndrome and their complications, and prolonged and/or recurrent cytopenia, which can all be fatal or life-threatening. Pyrexia, cytokine release syndrome, hypogammaglobulinemia, musculoskeletal pain, fatigue, infections, diarrhoea, nausea, encephalopathy, headache, coagulopathy, constipation, and vomiting were the most prevalent side effects of ciltacabtagene autoleucel.
CARVYKTI waxay leedahay qiimaynta halista iyo qorshaha dhimista oo u baahan cisbitaalada iyo rugaha caafimaadka qaybiya daawaynta si gaar ah loo shahaado si loo aqoonsado loogana hadlo CRS iyo sunta habdhiska dareenka. FDA waxay waydiisanaysaa shirkadda inay samayso daraasad indho-indhayn suuq-geyn kadib oo ku lug leh bukaannada lagu daweeyay ciltacabtagene autoleucel si loo qiimeeyo badbaadada muddada-dheer.
CARVYKTI waxa lagu bixiyaa qiyaas ah 0.5-1.0106 CAR-positive T-cells halkii kg ee miisaanka jidhka, oo leh qiyaasta ugu badan ee 1108 CAR-positive T-unugyada faleebo kasta.
