On May 27, 2022, FDA Tisagenlecleucel Accelerated Approval for the Treatment of Relapsed or Refractory Follicular Lymphoma After ≥ 2 Lines of Systemic Therapy
On May 27, 2022, FDA Tisagenlecleucel Accelerated Approval for the Treatment of Relapsed or Refractory Follicular Lymphoma After ≥ 2 Lines of Systemic Therapy
On May 27, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisagenlecleucel for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
This approval was based on the ELARA study (NCT03568461), a multicenter, single-arm, open-label study evaluating the efficacy and safety of the CD19-targeted CAR-T cell therapy tisagenlecleucel in patients with FL (refractory or relapsing within 6 months after completing ≥2 lines of treatment [including anti-CD20 antibody or alkylating agents] or relapsing after autologous hematopoietic stem cell transplantation). Following lymphodepleting chemotherapy, tisagenlecleucel was administered as a single intravenous infusion at a target dose of 0.6-6.0 x 10^8 CAR-positive viable T cells.
The primary efficacy endpoints were overall response rate (ORR) and duration of response (DOR), as determined by an independent review committee. In the primary efficacy analysis of 90 patients, the ORR was 86% (95% CI: 77, 92), with a complete response (CR) rate of 68% (95% CI: 57, 77). The median DOR was not reached, with 75% (95% CI: 63, 84) of responding patients remaining in response at 9 months. For all patients who underwent leukapheresis (n=98), the ORR was 86% (95% CI: 77, 92), and the CR rate was 67% (95% CI: 57, 76).
The most common (>20%) adverse reactions were cytokine release syndrome, infections, fatigue, musculoskeletal pain, headache, and diarrhea.
The recommended dose of tisagenlecleucel is 0.6-6.0 x 10^8 CAR-positive viable T cells.