FDA has granted an accelerated approval to tisagenlecleucel (Kymriah) for follicular lymphoma patients

June 3, 2022

On May 27, 2022 the FDA has granted an accelerated approval to tisagenlecleucel (Kymriah) for follicular lymphoma patients whose cancer has come back or progressed even after 2 or more lines of treatments.

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Tisagenlecleucel (Kymriah) is a chimeric antigen - receptor (CAR) - T cell therapy which was currently approved for the treatment of acute lymphoblastic leukemia (ALL) and B cell non-Hodgkin’s lymphoma (NHL) patients and made to target the protein called CD19 in cancer cells.     This approval was based on the phase 2 ELARA trial (NCT03568461), in which 86.2% of patients responded to the drug, and 66% of those who responded to the drug had no sign of cancer.  Moreover, among 31 patients whose cancer did not get any worse initially with the treatment, 12 patients eventually showed no sign of cancer after 3-6 months of the treatment.   

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The follicular lymphoma patients’ responses to tisagenlecleucel (Kymriah) are incredible, but 99% of the patients had side effects, and 76% of the patients experienced severe side effects which include cytokine release syndrome (CRS) and neurological adverse reaction.