2022 Juni: Saatos dua atanapi langkung jalur terapi sistemik, FDA masihan tisagenlecleucel (Kymriah, Novartis Pharmaceuticals Corporation) ngagancangkeun persetujuan pikeun penderita dewasa anu kambuh atanapi refractory follicular lymphoma (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.
Laju respon sakabéh (ORR) jeung durasi respon (DOR), sakumaha ngadegkeun ku panitia review bebas, éta ukuran efficacy utama. The ORR éta 86 persen (95 persen CI: 77, 92) diantara 90 penderita dina analisis efficacy primér, kalawan laju CR 68 persen (95 persen CI: 57, 77). DOR median henteu kapendak, kalayan 75% réspondén (95 persén CI: 63, 84) masih ngaréspon saatos 9 bulan. The ORR éta 86 persen (95 persen CI: 77, 92) pikeun sakabéh pasien anu miboga leukapheresis (n = 98), kalawan laju CR 67 persen (95 persen CI: 57, 76).
Sindrom sékrési sitokin, 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.
