FDA Approves Lisocabtagene Maraleucel for Adult Patients With R/R Follicular Lymphoma

On May 15th, 2024, the US Food and Drug Administration (FDA) granted accelerated approval to lisocabtagene maraleucel for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy.

This regulatory decision was based on results from the phase 2, open-label, multicenter, single-arm TRANSCEND-FL trial, which included patients with R/R FL after 2 or more lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent.

Patients received 1 dose of lisocabtagene maraleucel for 2 to 7 days after the completion of lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 300 mg/m²/day concurrently for 3 days.) The primary efficacy population included 94 patients with PET-positive disease at baseline or following bridging therapy, received the conforming product in the intended dose range, and had at least 9 months of follow up from first response.

The main efficacy outcome measures were overall response rate (ORR), defined as the percentage of patients with a best overall response of complete response or partial response after lisocabtagene maraleucel infusion, and duration of response (DOR) as determined by an independent review committee. The ORR was 95.7% (95% confidence interval [CI], 89.5 to 98.8). After a median follow-up of 16.8 months, the median DOR was not reached (NR; 95% CI, 18.04 to NR).

The most common non-laboratory adverse reactions, occuring in ≥20% of patients, were cytokine release syndrome (CRS), headache, musculoskeletal pain, fatigue, constipation, and fever. Due to the risk of fatal or life-threatening CRS and neurologic toxicities, this approval was granted with a Risk Evaluation and Mitigation Strategy.

The recommended lisocabtagene maraleucel dose is 90 to 110 × 10⁶ CAR-positive viable T-cells with a 1-to-1 ratio of CD4 and CD8 components.

Source:

FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma. Published online May 15, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-lisocabtagene-maraleucel-follicular-lymphoma