The Food and Drug Administration has approved Tecartus® (brexucabtagene autoleucel) for the treatment of adult patients 18 years of age and older with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Tecartus is an autologous, anti-CD19 chimeric antigen receptor (CAR) T-cell therapy. The approval was based on data from the open-label, single-arm, multicenter phase 1/2 ZUMA-3 trial (ClinicalTrials.gov Identifier: NCT02614066), which evaluated the efficacy and safety of Tecartus in 71 adults with relapsed or refractory B-cell precursor ALL. Patients received a single infusion of Tecartus following completion of lymphodepleting chemotherapy. The primary efficacy endpoint was overall complete remission rate, which included complete remission (CR) within 3 months after infusion and duration of CR.
Among 54 evaluable patients, results showed that 28 (52%; 95% CI, 38-66) achieved CR within 3 months. With a median follow-up for responders of 7.1 months, the median duration of CR was not reached. The median time to CR was 56 days (range: 25 to 86 days). The duration of CR was estimated to exceed 12 months for more than half the patients. The median duration of remission was 13.6 months among efficacy-evaluable patients.
“Adults with ALL face a significantly poorer prognosis compared to children, and roughly half of all adults with B-ALL will relapse on currently available therapies,” said Bijal Shah, MD, ZUMA-3 investigator and medical oncologist, Moffitt Cancer Center, Tampa, Florida. “A single infusion of Tecartus has demonstrated durable responses, suggesting the potential for long-term remission and a new approach to care.”
The most common non-laboratory treatment emergent adverse reactions included fever, cytokine-release syndrome, hypotension, encephalopathy, tachycardia, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection with pathogen unspecified, constipation, decreased appetite, and vomiting.
Tecartus carries a Boxed Warning for cytokine-release syndrome 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.
Tecartus is also indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. The product 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.
- FDA approves brexucabtagene autoleucel for relapsed or refractory B-cell precursor acute lymphoblastic leukemia. News release. US Food and Drug Administration. Accessed October 4, 2021. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brexucabtagene-autoleucel-relapsed-or-refractory-b-cell-precursor-acute-lymphoblastic.
- U.S. FDA approves Kite’s Tecartus® as the first and only CAR T for adults with relapsed or refractory B-cell acute lymphoblastic leukemia. News release. Kite Pharma, Inc. Accessed October 4, 2021. https://www.businesswire.com/news/home/20211001005719/en/U.S.-FDA-Approves-Kite%E2%80%99s-Tecartus%C2%AE-as-the-First-and-Only-Car-T-for-Adults-With-Relapsed-or-Refractory-B-cell-Acute-Lymphoblastic-Leukemia.
- Tecartus. Package insert. Kite Pharma, Inc.; 2021. Accessed October 4, 2021. https://www.gilead.com/-/media/files/pdfs/medicines/oncology/tecartus/tecartus-pi.pdf.