Agusta 2021: Cibiyar Abinci da Magunguna ta amince da idecabtagene vicleucel (Abecma, Bristol Myers Squibb) don kula da tsofaffi marasa lafiya tare da relapsed ko refractory mahara myeloma bayan hudu ko fiye da kafin layi na far, ciki har da wani immunomodulatory wakili, proteasome inhibitor, da kuma anti-CD38. monoclonal antibody. Wannan shine farkon jigon kwayar halitta don ƙwayoyin myeloma da yawa waɗanda FDA ta amince da su.
Idecabtagene vicleucel jiyya ce ta T-cell da aka kirkira ta autologous chimeric antigen receptor (CAR) wacce ke kaiwa ga B-cell maturation antigen (BCMA). Kowane kashi an keɓance shi da nasu T-cell na majiyyaci, waɗanda aka girbe, an canza su ta hanyar kwayoyin halitta, sannan a sake dawo da su cikin majiyyaci.
In a multicenter research, 127 patients with relapsed and refractory Multi myeloma who had undergone at least three prior lines of antimyeloma therapy were evaluated for safety and efficacy; 88 percent had received four or more prior lines of therapies. The efficacy of idecabtagene vicleucel at doses ranging from 300 to 460 x 106 CAR-positive T cells was studied in 100 individuals. The overall response rate (ORR), complete response (CR) rate, and duration of response (DOR) were calculated using the International Myeloma Working Group Uniform Response Criteria for Multiple Myeloma by an independent response committee.
ORR ya kasance 72 bisa dari (95 bisa dari CI: 62 bisa dari, 81 bisa dari), tare da kashi 28 bisa dari CR (95 bisa dari CI 19 bisa dari, 38 bisa dari). Jimlar kashi 65 cikin XNUMX na marasa lafiya da suka sami CR sun zauna a ciki na akalla shekara guda.
A boxed gargadi ga Ciwon saki na cytokine (CRS), neurologic toxicities, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and persistent cytopenias is included on the idecabtagene vicleucel label. CRS, infections, exhaustion, musculoskeletal pain, and hypogammaglobulinemia are the most prevalent side effects of idecabtagene vicleucel.
Idecabtagene vicleucel has a risk evaluation and mitigation plan that requires healthcare facilities dispensing the medicine to be specially certified in recognising and managing CRS and nervous system toxicities. The FDA is ordering the company to conduct a post-marketing observational study involving patients treated with idecabtagene vicleucel in order to assess long-term safety.
300 zuwa 460 106 CAR-tabbatacce Kwayoyin T shine adadin da aka ba da shawarar don idecabtagene vicleucel.
Magana: https://www.fda.gov/
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