FDA Approves Tisagenlecleucel for Relapsed/Refractory Follicular Lymphoma

This approval is based on data from the single-arm ELARA trial, which assessed tisagenlecleucel in adult patients who were refractory or relapsed within six 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 (HSCT).

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

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

Source: U.S. Food and Drug Administration press release, May 2022