Maris 2022: Bayan layukan jiyya huɗu ko fiye da suka gabata, gami da mai hana proteasome (PI), wakili na immunomodulatory (IMiD), da anti-CD38 monoclonal antibody, Hukumar Abinci da Magunguna ta amince da ciltacabtagene autoleucel. (CARVYKTI, Janssen Biotech, Inc.) don kula da manya marasa lafiya tare da relapsed ko refractory mahara myeloma.
Ciltacabtagene autoleucel shine ingantaccen injiniyar ƙwayoyin halitta autologous chimeric antigen receptor CAR T-cell therapy magani wanda ke kaiwa B-cell maturation antigen (BCMA). Kowane kashi an keɓance shi da nasu T-cell na majiyyaci, waɗanda aka girbe, an gyara su ta hanyar kwayoyin halitta, sannan a sake dawo da su cikin majiyyaci.
CARTITUDE-1 (NCT03548207) was an open label, multicenter gwajin gwaji that looked at the safety and efficacy of ciltacabtagene autoleucel in 97 patients with relapsed or refractory Multi myeloma 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 saki ciwo (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 yana da tsarin kimanta haɗari da tsarin ragewa wanda ke buƙatar asibitoci da asibitocin da ke rarraba maganin don a ba da takaddun shaida musamman don ganewa da magance CRS da ƙwayoyin cuta na tsarin juyayi. FDA tana tambayar kamfanin don gudanar da binciken lura bayan tallace-tallace wanda ya shafi marasa lafiya da aka yi da ciltacabtagene autoleucel don tantance aminci na dogon lokaci.
Ana ba da CARVYKTI a kashi na 0.5-1.0106 CAR-tabbatacce T-cells a kowace kilogiram na nauyin jiki, tare da matsakaicin adadin 1108 CAR-tabbatacce T-cells a kowace jiko.
