NgoJuni 8, i-US FDA igunyaze i-Venetoclax (i-VENCLEXTA, i-AbbVie Inc. ne-Genentech Inc.) yeziguli ezine-lymphocytic leukemia (CLL) noma i-lymphocytic lymphoma encane (SLL), ngokususwa noma ngaphandle kwe-17p, okungenani Yamukela ukwelashwa.
Ukuvunyelwa kusekelwe ku-MURANO (NCT02005471), i-randomized (1: 1), i-multicenter, isilingo esivulekile sokuqhathanisa i-rituximab ne-venetoclax (VEN + R) ne-bendamustine ne-rituximab (B + R & lt), iziguli ezingama-389 ezibizwa nge-CLL okungenani ukwelashwa okukodwa kwangaphambilini. Iziguli ze-VEN + R ziqedele le protocol. Amaviki ama-5 kanye nenani lemithi yokwelashwa kwe-venetoclax, lapho-ke ukuqala kwe-rituximab, yake yathola nsuku zonke i-400 mg venetoclax, izinyanga ezingama-24 sezizonke. I-Rituximab idinga ukwelashwa imijikelezo engu-6 kwiVenetoclax (Umjovo ongenayo we-375 mg / m2 ngosuku 1 lomjikelezo 1, 500 mg / m2 womjovo wokujova ngosuku 1 wemijikelezo 2-6, umjikelezo owodwa izinsuku ezingama-28). Iqembu lokulawula. Imijikelezo engu-6 ye-B + R & lt (umjikelezo ngamunye wezinsuku ezingama-28 no-1 wezinsuku ze-bendamustine 2mg / m 70 kanye ne-rituximab ngaphezulu kwemithamo namashejuli).
Hlola ukusinda okungenanqubekela phambili ( PFS ). Ngemuva kokulandelwa okuphakathi kwezinyanga ze-23, i-PFS ephakathi eqenjini le-VEN + R ayizange ifinyelelwe, uma kuqhathaniswa nezinyanga ze-18.1 eqenjini le-B + R. Izinga lokuphendula eliphelele eqenjini le-VEN + R lalingu-92 %, kanti lelo eqenjini le-B + R lalingu-72%.
Phakathi kweziguli ezelashwa nge-VEN + R, ukusabela okuvame kakhulu (izehlakalo ≥20%) kwakuyi-neutropenia, isifo sohudo, ukutheleleka okuphezulu komgudu wokuphefumula, ukukhathala, ukukhwehlela kanye nesicanucanu. Ama-64% alezi ziguli ayenebanga lesi-3 noma lesi-4 le-neutropenia, kanti ama-31% ayene-grade 4 neutropenia. Ukusabela okubi kakhulu kwenzeka ku-46% weziguli, ukutheleleka okunzima kwenzeka kwiziguli ezingama-21%, okuvame kakhulu yi-pneumonia (9%). Ngenxa yokwehla okusheshayo kwevolumu ye-tumor, i-tumor lysis syndrome (TLS) iyinto ebalulekile engcupheni yokwelashwa kweVenetoclax. Ukunakekelwa kufanele kuthathwe ngesikhathi sokwelashwa.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm610308.htm
