The Food and Drug Administration (FDA) has granted accelerated approval to Tecartus™ (brexucabtagene autoleucel; Kite Pharma) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

Tecartus is a chimeric antigen receptor (CAR) T-cell therapy that works by binding to CD19-expressing cancer cells and normal B cells. Tecartus is administered as a customized treatment using a patient’s own T cells that have been genetically modified to include a new gene to target and destroy lymphoma cells.

The approval is based on data from the ongoing single-arm, phase 2 ZUMA-2 study that evaluated the efficacy and safety of a single intravenous infusion of Tecartus in 60 adult patients with relapsed or refractory MCL who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a Bruton tyrosine kinase inhibitor (ibrutinib or acalabrutinib). The primary endpoint was objective response rate (ORR) per the Lugano Classification (2014) as assessed by an independent radiologic review committee.

Results showed an ORR of 87% (n=52; 95% CI, 75-94), with 62% of patients (n=37; 95% CI, 48-74) achieving complete remission and 25% (n=15; 95% CI, 15-38) achieving partial remission. The median duration of response has not yet been reached.

“Many patients have high-risk disease and are more likely to keep progressing, even after subsequent treatments,” said Michael Wang, MD, ZUMA-2 Lead Investigator and Professor, Department of Lymphoma and Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. “The availability of Tecartus as the first-ever cell therapy for patients with relapsed/refractory MCL provides an important option with a response rate of nearly 90% and early clinical evidence suggesting durable remissions in later lines of therapy.”

With regard to safety, the most common non-laboratory adverse reactions (≥20%) included  pyrexia, cytokine release syndrome (CRS), hypotension, encephalopathy, fatigue, tachycardia, arrhythmia, infection, chills, hypoxia, cough, tremor, musculoskeletal pain, headache, nausea, edema, motor dysfunction, constipation, diarrhea, decreased appetite, dyspnea, rash, insomnia, pleural effusion, and aphasia. 

Tecartus carries a Boxed Warning for CRS and neurologic toxicities. Due to these potentially life-threatening reactions, the treatment is only available through a restricted program called the Yescarta and Tescartus REMS program.

Continued approval of Tecartus for the treatment of relapsed or refractory MCL may be contingent upon verification and description of clinical benefit in confirmatory trials. The FDA is also requiring a postmarketing observational study to evaluate long-term safety.

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Tecartus is supplied in an infusion bag containing approximately 68mL of frozen suspension of genetically modified autologous T cells in 5% DMSO and human serum albumin. According to the Company, the median manufacturing turnaround time is 15 days from leukapheresis to product delivery.

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