Yuni 2022: Bayan layi biyu ko fiye na tsarin jiyya, FDA ta ba da tisagenlecleucel (Kymriah, Novartis Pharmaceuticals Corporation) da sauri yarda ga manya marasa lafiya tare da relapsed ko refractory follicular lymphoma (FL).
Amincewar ta dogara ne akan sakamakon gwajin ELARA (NCT03568461), cibiyar sadarwa mai yawa, hannu ɗaya, gwajin alamar buɗaɗɗen kimantawa tisagenlecleucel, CD19-directed chimeric antigen receptor (CAR) T cell therapy, a cikin manya marasa lafiya waɗanda ke ƙin yarda ko sake dawowa a cikin watanni 6 bayan kammala layi biyu ko fiye na tsarin tsarin tsarin jiki (ciki har da anti-CD20 antibody da alkylating agent) ko Tisagenlecleucel an ba shi azaman jiko guda ɗaya na jini bayan lymphodepleting chemotherapy, tare da manufa na 0.6 zuwa 6.0 x 108 CAR- ingantattun ƙwayoyin T masu ƙarfi.
Adadin amsa gabaɗaya (ORR) da tsawon lokacin amsawa (DOR), kamar yadda kwamitin bita mai zaman kansa ya kafa, sune manyan matakan inganci. ORR ya kasance kashi 86 cikin dari (95 bisa dari CI: 77, 92) tsakanin marasa lafiya na 90 a cikin ƙididdigar inganci na farko, tare da ƙimar CR na 68 bisa dari (95 bisa dari CI: 57, 77). Ba a sadu da matsakaicin DOR ba, tare da 75% na masu amsa (95 bisa dari CI: 63, 84) har yanzu suna amsawa bayan watanni 9. ORR ya kasance kashi 86 bisa dari (95 bisa dari CI: 77, 92) ga duk marasa lafiya da ke da leukapheresis (n=98), tare da adadin CR na 67 bisa dari (95 bisa dari CI: 57, 76).
Ciwon saki na 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.
