Originally published by our sister publication Clinical Oncology News

By Clinical Oncology News Staff

The FDA has granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics) for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.

Efficacy was evaluated in TRANSCEND-FL (ClinicalTrials.gov Identifier: NCT04245839), a phase 2, open-label, multicenter, single-arm trial in adults with relapsed or refractory FL after two or more lines of systemic therapy, including an anti-CD20 antibody and alkylating agent. Patients were eligible to enroll in the study if they had adequate bone marrow function to receive lymphodepleting chemotherapy and an ECOG Performance Status of 1 or less.

Patients could receive bridging therapy for disease control after apheresis and prior to lymphodepletion and subsequent administration of lisocabtagene maraleucel. Patients received a single dose of lisocabtagene maraleucel two to seven days, following the completion of lymphodepleting chemotherapy (fludarabine 30 mg/m² per day and cyclophosphamide 300 mg/m² per day concurrently for three days). The primary efficacy population included 94 patients with PET-positive disease at baseline or after bridging therapy, received conforming product in the intended dose range, and had at least nine 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% CI, 89.5%-98.8%). After a median follow-up of 16.8 months (95% CI, 16.3-17.0 months), the median DOR was not reached (NR) (95% CI, 18.04 months to NR).

The most common non-laboratory adverse reactions (≥20%) were cytokine release syndrome (CRS), headache, musculoskeletal pain, fatigue, constipation and fever. The FDA approved lisocabtagene maraleucel with a Risk Evaluation and Mitigation Strategy due to the risk for fatal or life-threatening CRS and neurologic toxicities.

The full prescribing information for lisocabtagene maraleucel  is be posted here.

Based on a press release from the FDA.