FDA D.I.S.C.O. Burst Edition: Breyanzi (lisocabtagene maraleucel)
Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide another quick update on a recent FDA cancer therapeutic approval.
On February 5, 2021, the FDA approved lisocabtagene maraleucel (brand name Breyanzi) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (or DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.
Lisocabtagene maraleucel is a CD19-directed chimeric antigen receptor or CAR T cell immunotherapy. It consists of autologous T cells that are genetically modified to produce a CAR protein, allowing the T cells to identify and eliminate CD19-expressing normal and malignant cells.
Efficacy was evaluated in TRANSCEND, a single-arm, open label, multicenter trial that evaluated lisocabtagene maraleucel, preceded by lymphodepleting chemotherapy, in adults with relapsed or refractory large B-cell lymphoma after at least two lines of therapy.
Of the 192 patients evaluable for response, the overall response rate per independent review committee assessment was 73% with a complete response rate of 54%. The median time to first response was one month. Of the 104 patients who achieved complete response, 65% had remission lasting at least 6 months and 62% had remission lasting at least 9 months. The estimated median duration of response was not reached in patients who achieved a complete response. The estimated median duration of response among patients with partial response was 1.4 months.
Cytokine release syndrome occurred in 46% of patients, 4% having Grade 3 or higher and neurologic toxicity occurred in 35%, with 12% having Grade 3 or higher. Three patients had fatal neurologic toxicity. Other Grade 3 or higher adverse reactions included infections at 19% and prolonged cytopenia’s at 31%. FDA approved lisocabtagene maraleucel with a Risk Evaluation and Mitigation Strategy because of the risk of fatal or life-threatening cytokine release syndrome and neurologic toxicities.
Full prescribing information for this approval can be found on the web at www.fda.gov, with key word search “Approved Cellular and Gene Therapy Products”.