Brexucabtagene autoleucel waxa u ansixisay FDA dib u soo noqoshada ama dib u soo noqoshada unugyada B-cell ee leukemia ba'an

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Oktoobar 2021: Brexucabtagene autoleucel (Tecartus, Kite Pharma, Inc.) ay u ansixisay Maamulka Cuntada iyo Dawooyinka ee bukaanada qaangaarka ah ee leh soo noqoshada unugyada B-unugyada lymphoblastic leukemia ba'an (ALL).

Gudaha ZUMA-3 (NCT02614066), tijaabin hal gacan ah oo xarun badan oo shakhsiyaadka leh soo noqnoqda ama horudhaca unugyada B-unugyada ALL, wax ku oolnimada brexucabtagene autoleucel, a CD19-ku hagaya chimeric antigen reseptor (CAR) Daaweynta unugyada T-cell, ayaa la qiimeeyay. Ka dib daawaynta kiimoterabiga lymphodepleting, bukaanku waxay heleen hal faleebo oo ah brexucabtagene autoleucel.

Jawaabta dhamaystiran (CR) 3 bilood gudahood ee faleebada iyo adkeysiga CR ayaa ahaa shuruudaha natiijada waxtarka leh ee loo isticmaalo in lagu taageero oggolaanshaha. Saddex bilood gudahood, 28 (52 boqolkiiba; 95 boqolkiiba CI: 38, 66) ee bukaannada 54 ee lagu qiimeeyay waxtarka waxay heleen CR. Muddada dhexdhexaadka ah ee CR lama kulmin dabagal dhexdhexaad ah oo bilaha 7.1 ee jawaabayaasha; dhererka CR ayaa la filayaa inuu dhaafo 12 bilood in ka badan kala badh bukaannada.

Digniin feedh ah oo loogu talagalay 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.

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