FDA Approves Tisagenlecleucel for Advanced Follicular Lymphoma

June 06, 2022

The Food and Drug Administration recently approved tisagenlecleucel (Kymriah, Novartis) for adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. Tisagenlecleucel is an autologous chimeric antigen receptor (CAR) T-cell therapy that targets the CD19 protein common to B cells.

The approval is based on findings from the Phase II ELARA trial, which evaluated 90 patients for efficacy with a median follow-up of 17 months. Of these patients, 86% achieved a response, including 68% who experienced a complete response. Of 97 patients evaluable for safety at 21 months of median follow-up, 53% experienced any-grade cytokine release syndrome (0% grade 3 or higher) and 43% of patients experienced any-grade neurologic events (6% grade 3 or higher).

The prescribing information for tisagenlecleucel includes a boxed warning for cytokine release syndrome and neurologic toxicities. The therapy is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Kymriah REMS Program.

FDA has previously approved tisagenlecleucel pediatric and young adult patients with r/r B-cell precursor acute lymphoblastic leukemia. Tisagenlecleucel is also approved to treat adult patients with r/r large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL), and high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma. The European Commission also approved tisagenlecleucel for r/r FL last month.