Október 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 bráð eitilfrumuhvítblæði (ALL).
In ZUMA-3 (NCT02614066), a single-arm multicenter trial in individuals with relapsed or refractory B-cell precursor ALLT, 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.
Heildarsvörun (CR) innan 3 mánaða frá innrennsli og endingu CR voru niðurstöðuviðmiðin fyrir verkun sem notuð voru til að styðja við samþykki. Innan þriggja mánaða náðu 28 (52 prósent; 95 prósent CI: 38, 66) af þeim 54 sjúklingum sem metin voru með tilliti til virkni CR. Miðgildi lengdar CR var ekki mætt með miðgildi eftirfylgni 7.1 mánuður fyrir svörun; Gert var ráð fyrir að lengd CR myndi fara yfir 12 mánuði hjá meira en helmingi sjúklinganna.
Viðvörun í kassa fyrir cýtókínlosunarheilkenni (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.