Bishii Juun 8, US FDA waxay ansixisay Venetoclax (VENCLEXTA, AbbVie Inc. iyo Genentech Inc.) bukaanada qaba leukemia lymphocytic chronic (CLL) ama lymphocytic lymphoma yar (SLL), oo leh ama aan lahayn 17p tirtirka, ugu yaraan la helay daaweyn.
Ansixinta waxay ku saleysan tahay MURANO (NCT02005471), oo la kala soocay (1: 1), multicenter, tijaabo furan oo isbarbardhigaya rituximab oo leh venetoclax (VEN + R) iyo bendamustine oo leh rituximab (B + R & lt), 389 magac bukaanno CLL laga helay ugu yaraan hal daaweyn hore. Bukaannada VEN + R ayaa dhammaystiray borotokoolka. 5 toddobaad iyo xaddiga habka daaweynta venetoclax, ka dib bilawga rituximab, ayaa mar la helay maalin kasta 400 mg venetoclax, wadar ahaan 24 bilood. Rituximab waxay u baahan tahay in lagu daaweeyo 6 wareeg oo ku saabsan Venetoclax (Cirbadda xididka ee 375 mg / m2 maalinta 1 ee wareegga 1, 500 mg / m2 ee duritaanka xididka maalinta 1 ee wareegyada 2-6, hal wareeg 28 maalmood). Kooxda xakamaynta. 6 wareeg oo ah B + R & lt (maalin kasta 28 wareega 1 iyo 2 maalmood bendamustine 70mg / m 2 iyo rituximab oo ka sarreeya qiyaasaha iyo jadwalka).
Qiimee badbaadada aan horumarka lahayn (PFS). Ka dib dabagal dhexdhexaad ah oo 23 bilood ah, dhexdhexaadiyaha PFS ee kooxda VEN + R lama gaarin, marka la barbar dhigo 18.1 bilood ee kooxda B + R. Wadarta heerka jawaabta kooxda VEN + R waxay ahayd 92 %, halka kooxda B + R ay ahayd 72 %.
Bukaannada lagu daweeyey VEN + R, falcelinta xun ee ugu badan (dhacdooyinka ≥ 20%) waxay ahaayeen neerofayn, shuban, infekshinka mareenka sare, daal, qufac iyo lallabo. 64% bukaanadan waxay qabeen fasalka 3 ama 4 neutropenia, iyo 31% waxay qabaan 4 fasalka 46. Falcelisyo daran oo daran ayaa ka dhacay 21% bukaanno, infekshanno daran ayaa ku dhacay 9% bukaannada, kuwa ugu badan waxay ahaayeen oof-wareen (XNUMX%). Sababtoo ah hoos u dhaca degdega ah ee mugga burooyinka, cilladda lysis syndrome (TLS) ayaa ah qodob muhiim u ah daaweynta Venetoclax. Daryeelka waa in la qaadaa inta lagu jiro daaweynta.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm610308.htm
