August 2021: Maamulka Cuntada iyo Dawooyinka ayaa ansixiyay idecabtagene vicleucel (Abecma, Bristol Myers Squibb) ee loogu talagalay daawaynta bukaanada qaangaarka ah ee leh soo noqnoqoshada ama dib-u-celinta multiple myeloma ka dib afar ama in ka badan oo daawaynta hore ah, oo ay ku jiraan wakiilka immunomodulatory, proteasome inhibitor, iyo anti-CD38 monoclonal antibody. Tani waa daawaynta hidda-wadaha unugga-ku-saleysan ee ugu horreeya ee loo yaqaanno myeloma-ka badan ee ay ansixisay FDA.
Idecabtagene vicleucel waa daawaynta unugyada T-unuga ee loo yaqaan 'kimeric antigen reseptor' (CAR) kaas oo bartilmaameedsada antigen-ka korriinka unugyada B-cell (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.
In a multicenter research, 127 patients with relapsed and refractory Meelo badan 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 wuxuu ahaa boqolkiiba 72 (95 boqolkiiba CI: 62 boqolkiiba, 81 boqolkiiba), oo leh 28 boqolkiiba heerka CR (95 boqolkiiba CI 19 boqolkiiba, 38 boqolkiiba). Wadar ahaan 65 boqolkiiba bukaannada gaaray CR ayaa ku jiray ugu yaraan hal sano.
Digniin feedh ah oo loogu talagalay 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 ilaa 460 106 C-positive T unugyada T waa qiyaasta qiyaasta qiyaasta ee loogu talagalay vicleucel idecabtagene.
Tixraac: https://www.fda.gov/
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