June 2022: Post duos vel plures lineas systemicae therapiae, FDA consideratum tisagenlecleucel (Kymriah, Novartis pharmaceutica Corporation) approbationem expedivit adultis aegris cum relapso vel refractorio lymphoma folliculari (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.
Suprema responsionis rate (ORR) et duratio responsionis (DOR), prout ex commissione independenti comprobata, maioris efficaciae mensurae erant. ORR 86 centesimas (95 percent CI: 77, 92) inter 90 aegros in analysi efficacia primario, cum rate CR 68 centesimis (95 percent CI: 57, 77). Mediana DOR non occurrit, cum 75% conventi (95 percent CI: 63, 84) respondet adhuc post 9 menses. ORR erat 86 centesimas (95 cento CI: 77, 92) omnibus aegris qui leukapheresim habebant (n=98), cum ratam CR 67 centesimis (95 percent CI: 57, 76).
Citoquina release syndrome, 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.
