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I-FDA ivuselela umuthi wemithi we-lymphocytic leukemia

Yabelana ngalokhu okuthunyelwe

I-US Food and Drug Administration igunyaze i-Venetoclax (i-Venclexta) ehlanganiswe ne-rituximab (VenR) yokwelashwa kweziguli ezine-lymphocytic leukemia (CLL) engapheli ngokusekelwe kudatha encane ye-residual (MRD) yesigaba sesi-III sesivivinyo se-MURANO, futhi ukusebenza kahle kangcono kakhulu Ngokuhambisana nohlobo lwe-bendamustine kanye ne-rituximab (BR).

Ucwaningo lwe-MURANO luthole ukuthi ukusebenza kwe-chemoimmunotherapy kwe-CLL kuhlobene nokuthi kungenzeka yini ukufeza ukuguqulwa kwe-MRD, nokuthi ukusebenza kokwelashwa kwezidakamizwa okuhlosiwe kwe-CLL ephikisayo noma ebuyisiwe kuhlobene nokuguqulwa kwe-MRD, ngoba izinga lokuguqulwa kwe-MRD kulezi ziguli okungaziwa. phansi.

Ucwaningo lwe-MURANO lubonise ukuthi uhlobo lwe-VenR lwalune-PFS engcono ye-CLL ephikisayo noma ebuyele emuva uma iqhathaniswa ne-BR regimen (HR0.17), futhi i-MRD yegazi le-peripheral nomnkantsha wamathambo waphenduka waba mubi. Ukuguqulwa kwe-MRD ibe okungalungile eqenjini le-VenR kwakungahlobene nokuthi isiguli sine-del (17p), ukuguqulwa okungeyona i-IGVH, ukuguqulwa kwe-TP53 nezinye izici ezimbi zokubikezela. Eqenjini le-VenR, iziguli eziyi-121/194 (62%) zazine-MRD negative ekupheleni kokwelashwa okuhlangene. Ekulandeleni okuphakathi kwezinyanga ezingu-13.8 (izinyanga ezingu-5.6-23.0), iziguli ze-100 (83%) zazisene-MRD engalungile kanye neziguli ze-2 Ukuqhubekela phambili ku-PD, amacala angu-2 abulawa yisifo esingenamsebenzi, amacala angu-2 aqhubekela phambili ku-Richter's syndrome, amacala angu-15 ( 12%) i-MRD yaphenduka yaba phozithivu [1 icala MRD≥10 ^ (-2) kanye PD, 14 amacala MRD 10 ^ (-4) ~ <10 ^ (-2) futhi 2 kuwo kwaba PD, 1 washona, 11 namanje yayingenantuthuko.

Ukwelashwa kwe-VenR kwe-CLL ephikisayo noma ebuyiselwe emuva inezinga eliphakeme lokungaguquguquki ekutholeni ukuguqulwa kwegazi lomnkantsha kanye nomnkantsha we-MRD, futhi isimo se-peripheral blood MRD sihlobene kakhulu nokusebenza komtholampilo. I-VenR ingavumela iziguli ukuthi zithole izinga lokuguqulwa kwegazi le-MRD elijulile futhi eliqinile zisencane, futhi akuhlangene nokuthi iziguli zinezici ezimbi zokubikezela, ezingcono kakhulu kunohlelo lwe-BR. Ukuphindeka kwe-MRD kubonakala kuphela ezigulini ezimbalwa futhi kungahle kungaholi ekuqhubekeni kwesifo somtholampilo. Kuphakanyiswa ukuthi ukusebenza kweVenR kungcono kakhulu kunerejimeni ye-BR, futhi njengamanje kuwuhlobo lwemithi olunconywayo lwe-CLL ephikisayo noma ebuyile.

https://www.onclive.com/web-exclusives/fda-updates-venetoclax-cll-label-with-mrd-data

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