Agasti 2021: I-Food and Drug Administration igunyaze i-idecabtagene vicleucel (Abecma, Bristol Myers Squibb) yokwelashwa kweziguli ezikhulile ezine-myeloma eminingi ebuyele emuva noma ephikisayo ngemva kwemigqa yokwelashwa emine noma ngaphezulu yangaphambili, okuhlanganisa i-ejenti evikela umzimba, i-proteasome inhibitor, kanye ne-anti-CD38. I-antibody ye-monoclonal. Lokhu ukwelashwa kofuzo kokuqala okusekelwe kumaseli kwe-myeloma eminingi okugunyazwe yi-FDA.
I-Idecabtagene vicleucel iwufuzo yokwelapha ye-autologous chimeric antigen receptor (CAR) T-cell eqondiswe ngofuzo eqondise i-B-cell maturation antigen (BCMA). Umthamo ngamunye wenzelwe ama-T-cell esiguli, avunwa, ashintshwe izakhi zofuzo, bese ebuyiselwa esigulini.
In a multicenter research, 127 patients with relapsed and refractory i-myeloma eminingi 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.
I-ORR yayingamaphesenti angu-72 (amaphesenti angu-95 CI: amaphesenti angu-62, amaphesenti angu-81), amaphesenti angu-28 amaphesenti angu-CR (amaphesenti angu-95 CI 19 amaphesenti, amaphesenti angu-38). Isamba esingamaphesenti angama-65 eziguli ezithole i-CR zahlala kuyo okungenani unyaka.
Isexwayiso esisebhokisini se i-cytokine release syndrome (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 kuya ku-460 106 T amaseli e-CAR-positive ububanzi bomthamo ophakanyisiwe we-idecabtagene vicleucel.
Inkomba: https://www.fda.gov/
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