August 2021: Cibus et medicamentum administrationis idecabtageni vicleucelis approbavit (Abecma, Bristol Myers Squibb) ad curationem aegrorum adultorum cum relapso vel refractorio multiplex myeloma post quattuor vel plures priores lineas therapiae, incluso agente immunomodulatorio, proteasome inhibitore, et anti-CD38. monoclonal antibody. Haec est prima cellula-substructio gene therapiae pro myeloma multiplex quod FDA probatum est.
Idecabtagen vicleucel est genetice machinator antigenus chimaericus autologus receptor (CAR) T-cellula curatio quae peltat antigenum maturationis B-cell (BCMA). Uterque dosis ad proprias cellulas T formandam est, quae metuuntur, genere modificantur, et in passum rettuli.
In a multicenter research, 127 patients with relapsed and refractory multa 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 quod erat LXXII percent (XCV percent ita fiat CI LXII cento, LXXXI percent) XXVIII percent et rate C. (C. XIX percent XCV percent: XXXVIII percent). A summa LXV percent attenditur C. de aegris qui fuerunt in ea saltem per annum.
Monitum cohibenti cytokine syndrome release (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 CKS 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 ad 460 106 cellae CAR-positivae T pro idecabtagen vicleucel range suggessit.
Reference: https://www.fda.gov/
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