Iyun 2022: Ikki yoki undan ortiq tizimli terapiyadan so'ng, FDA tisagenlecleucel (Kymriah, Novartis Pharmaceuticals Corporation) relapsli yoki refrakter follikulyar limfoma (FL) bo'lgan kattalardagi bemorlarga tez ruxsat berdi.
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.
Mustaqil ko'rib chiqish qo'mitasi tomonidan belgilangan umumiy javob darajasi (ORR) va javob davomiyligi (DOR) samaradorlikning asosiy chora-tadbirlari bo'ldi. Birlamchi samaradorlik tahlilida 86 bemor orasida ORR 95 foizni (77 foiz CI: 92, 90), CR darajasi esa 68 foizni (95 foiz CI: 57, 77) tashkil etdi. O'rtacha DOR bajarilmadi, respondentlarning 75 foizi (95 foiz CI: 63, 84) 9 oydan keyin ham javob berishdi. Leykaferez (n=86) bilan og'rigan barcha bemorlar uchun ORR 95 foizni (77 foiz CI: 92, 98), CR darajasi 67 foizni (95 foiz CI: 57, 76) tashkil etdi.
Sitokinni chiqarish sindromi, 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.
