Márta 2022: Tar éis ceithre líne teiripe nó níos mó roimh ré, lena n-áirítear coscaire proteasome (PI), gníomhaire inmunomodulatory (IMiD), agus antashubstaint monoclónach frith-CD38, tá ciltacabtagene autoleucel ceadaithe ag an Riarachán Bia agus Drugaí. (CARVYKTI, Janssen Biotech, Inc.) chun cóireáil a dhéanamh ar othair aosacha a bhfuil miólóma iolrach athiompaithe nó teasfhulangach orthu.
Is éard atá i Ciltacabtagene autoleucel ná cóireáil theiripe T-chealla CAR receptor antaigin chimeric uathlógach uathlógach 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.
CARTITUDE-1 (NCT03548207) was an open label, multicenter triail chliniciúil that looked at the safety and efficacy of ciltacabtagene autoleucel in 97 patients with relapsed or refractory il-mhóilíní who had received at least three prior lines of therapy, including a PI, an IMiD, and an anti-CD38 monoclonal antibody, and who had disease progression on or after the last chemotherapy regimen Patients were given 0.51.0106 CAR-positive viable T cells per kg body weight of ciltacabtagene autoleucel. Efficacy was determined by an Independent Review committee utilising the International Myeloma Working Group Uniform Response Criteria for Multiple Myeloma to assess overall response rate (ORR) and duration of response (DOR). The ORR was 97.9% (95 percent confidence interval: 92.7 percent, 99.7%). The median duration of response (DOR) was 21.8 months (95 percent CI: 21.8, NE) among the 95 patients who responded, with a median follow-up period of 18 months.
The CARVYKTI label includes a boxed warning for siondróm scaoileadh cytokine (CRS), hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), Parkinsonism and Guillain-Barré syndrome and their complications, and prolonged and/or recurrent cytopenia, which can all be fatal or life-threatening. Pyrexia, cytokine release syndrome, hypogammaglobulinemia, musculoskeletal pain, fatigue, infections, diarrhoea, nausea, encephalopathy, headache, coagulopathy, constipation, and vomiting were the most prevalent side effects of ciltacabtagene autoleucel.
Tá plean meastóireachta agus maolaithe riosca ag CARVYKTI a éilíonn go bhfuil deimhniú ar leith ag ospidéil agus clinicí a dháileann an teiripe chun tocsaineachtaí CRS agus néarchórais a aithint agus aghaidh a thabhairt orthu. Tá an FDA ag iarraidh ar an gcuideachta staidéar breathnadóireachta iar-mhargaíochta a dhéanamh ar othair a bhfuil cóireáil orthu le ciltacabtagene autoleucel chun sábháilteacht fhadtéarmach a mheasúnú.
Tugtar CARVYKTI ag dáileog de 0.5-1.0106 T-chealla inmharthana CAR-dearfach in aghaidh an kg de mheáchan coirp, le dáileog uasta de 1108 T-chealla inmharthana CAR-dearfach in aghaidh an insileadh.
