June 2022: Tar éis dhá líne nó níos mó de theiripe sistéamach, bhronn an FDA faomhadh gasta ar tisagenlecleucel (Kymriah, Novartis Pharmaceuticals Corporation) d’othair aosacha a raibh liomfoma follicular athiompaithe nó teasfhulangach (FL).
The approval was based on the results of the ELARA trial (NCT03568461), a multicenter, single-arm, open-label trial evaluating tisagenlecleucel, a CD19-directed chimeric antigen receptor (CAR) T cell therapy, in adult patients who were refractory or relapsed within 6 months after completing two or more lines of systemic therapy (including an anti-CD20 antibody and an alkylating agent) or Tisagenlecleucel was given as a single intravenous infusion after lymphodepleting chemotherapy, with a target dosage of 0.6 to 6.0 x 108 CAR-positive viable T cells.
Ba iad an ráta freagartha foriomlán (ORR) agus fad na freagartha (DOR), mar a bhunaigh coiste athbhreithnithe neamhspleách, na mórbhearta éifeachtúlachta. Bhí an ORR 86 faoin gcéad (95 faoin gcéad CI: 77, 92) i measc 90 othar san anailís éifeachtúlachta príomhúil, le ráta CR de 68 faoin gcéad (95 faoin gcéad CI: 57, 77). Níor comhlíonadh an DOR airmheánach, le 75% de na freagróirí (95 faoin gcéad CI: 63, 84) fós ag freagairt tar éis 9 mí. Ba é an ORR ná 86 faoin gcéad (95 faoin gcéad CI: 77, 92) do gach othar a raibh leukapheresis (n=98), le ráta CR de 67 faoin gcéad (95 faoin gcéad CI: 57, 76).
Siondróm scaoileadh cytokine, infection, weariness, musculoskeletal pain, headache, and diarrhoea were the most prevalent adverse effects in patients (>20 percent). 0.6 to 6.0 x 108 CAR-positive viable T cells is the suggested tisagenlecleucel dose.
