FDA Approved Tisagenlecleucel for R/R Follicular Lymphoma

The U.S. Food and Drug Administration (FDA) has granted tisagenlecleucel accelerated approval for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

This approval is based on data from the ELARA trial, which was a single-arm trial testing tisagenlecleucel in adult patients who were refractory or relapsed within 6 months after completion of two or more lines of therapies (including an anti-CD20 antibody and an alkylating agent) or those who relapsed after autologous hematopoietic stem cell transplant.

Among 90 patients in the primary efficacy analysis, the overall response rate was 86%, with a complete response rate of 68%. Median duration of response was not reached. Three-fourths of responders were still in response at 9 months.

The most common adverse reactions (>20%) were cytokine release syndrome, infection, fatigue, musculoskeletal pain, headache, and diarrhea.

Source: FDA Press Release, May 2022