Lúnasa 2021: Cheadaigh an Riarachán Bia agus Drugaí idecabtagene vicleucel (Abecma, Bristol Myers Squibb) chun cóireáil a dhéanamh ar othair aosacha a bhfuil miolóma iolrach athiompaithe nó teasfhulangach orthu tar éis ceithre líne teiripe nó níos mó, lena n-áirítear oibreán inmunomodulatory, coscaire proteasome, agus frith-CD38 antashubstaint mhonaclónach. Is é seo an chéad ghéinteiripe cille-bhunaithe le haghaidh mialóma iolrach atá ceadaithe ag an FDA.
Is éard atá i Idecabtagene vicleucel ná cóireáil T-chealla receptor antaigin chimeric uathlógach uathlógach (CAR) a dhéantar a innealtóireacht go géiniteach a dhíríonn ar antaigin aibithe B-chealla (BCMA). Déantar gach dáileog a shaincheapadh do chealla T an othair féin, a bhuaintear, a mhodhnaítear go géiniteach, agus a thugtar isteach san othar arís.
In a multicenter research, 127 patients with relapsed and refractory il-mhóilíní 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.
Ba é an ORR 72 faoin gcéad (95 faoin gcéad CI: 62 faoin gcéad, 81 faoin gcéad), le ráta CR 28 faoin gcéad (95 faoin gcéad CI 19 faoin gcéad , 38 faoin gcéad ). D'fhan 65 faoin gcéad de na hothair a bhain CR amach ann ar feadh bliana ar a laghad.
Rabhadh i mboscaí le haghaidh siondróm scaoileadh 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 go 460 106 Is é cealla T CAR-dearfach an raon dáileog a mholtar le haghaidh idecabtagene vicleucel.
Tagairt: https://www.fda.gov/
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