Oktubre 2021: Brexucabtagene autoleucel (Tecartus, Kite Pharma, Inc.) has been approved by the Food and Drug Administration for adult patients with relapsed or refractory B-cell precursor talamak na lymphoblastic leukemia (LAHAT).
In ZUMA-3 (NCT02614066), a single-arm multicenter trial in individuals with relapsed or refractory B-cell precursor LAHAT, the efficacy of brexucabtagene autoleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell treatment, was assessed. Following lymphodepleting chemotherapy, patients received a single infusion of brexucabtagene autoleucel.
Ang kumpletong pagtugon (CR) sa loob ng 3 buwan ng pagbubuhos at tibay ng CR ay ang pamantayan sa pagiging epektibo ng resulta na ginamit upang suportahan ang pag-apruba. Sa loob ng tatlong buwan, 28 (52 porsiyento; 95 porsiyento CI: 38, 66) ng 54 na pasyenteng nasusuri para sa pagiging epektibo ay nakamit ang CR. Ang median na tagal ng CR ay hindi natugunan ng median na follow-up na 7.1 buwan para sa mga tumugon; ang haba ng CR ay inaasahang lalampas sa 12 buwan para sa higit sa kalahati ng mga pasyente.
Isang nakakahon na babala para sa cytokine release syndrome (CRS) and neurologic toxicities is included in the prescribing material for brexucabtagene autoleucel. In 92 percent of cases (Grade 3, 26 percent), CRS developed, and in 87 percent of cases (Grade 3, 35 percent), neurologic toxicities occurred. Fever, CRS, hypotension, encephalopathy, tachycardias, nausea, chills, headache, fatigue, febrile neutropenia, diarrhoea, musculoskeletal pain, hypoxia, rash, edoema, tremor, infection with an unspecified pathogen, constipation, decreased appetite, and vomiting were the most common non-laboratory adverse reactions (incidence 20%).
A single intravenous infusion of 1 x 106 CAR-positive viable T cells per kg body weight (maximum 1 x 108 CAR-positive viable T cells) is advised for brexucabtagene autoleucel treatment, followed by fludarabine and cyclophosphamide for lymphodepleting chemotherapy.
