I-Asciminib (i-Scemblix) yeSando sokuFunyaniswa kwe-Cronic Myeloid Leukemia (CML)

I-Asciminib (i-Scemblix) ivunyiwe kwizigulane zabantu abadala abane-Philadelphia chromosome-positive chronic myeloid leukemia (Ph + CML) kwisigaba esingapheliyo (CP). Ulwamkelo olukhawulezileyo lwavunywa ngabakwa FDA 29 Oktobha 2024.

Kwangoko, i-asciminib yamkelwe yi-FDA ngo-Okthobha ka-2021 kwaye ngo- ema ngo-Agasti 2022 kunyango lwabantu abadala abane-Ph + CML kwisigaba esingapheliyo (CML-CP), ngaphambili baphathwa nge-≥ 2 TKIs, kunye nonyango lwabantu abadala abane-Ph + CML-CP kunye nokuguqulwa kwe-T315I.

Ichiza laliphantsi kovavanyo lweklinikhi lokuvavanya ukusebenza kwalo kunye nokhuseleko kumgca wokuqala, umgca wamva kunye nezigulane zabantwana ezine-CML.

Ulwamkelo olutsha lwabantu abasanda kufunyaniswa ukuba bane-CML lusekwe kwimpumelelo kunye nedatha yokhuseleko evela kulingo. Ukuphumelela kwe-asciminib kwi-Ph + CML esanda kufunyaniswa kwi-CP yavavanywa kwi-ASC4FIRST (NCT04971226) yovavanyo apho izigulane ze-405 zazingahleliwe (1: 1) ukufumana i-asciminib okanye i-tyrosine kinase inhibitors ekhethiweyo ngumphandi (IS-TKIs). Umlinganiselo oyintloko wesiphumo sokuphumelela wawuyimpendulo enkulu yeemolekyuli (MMR) kwiiveki ze-48. Ezona mpendulo zixhaphakileyo (≥20%) yayizintlungu ze-musculoskeletal, irhashalala, ukudinwa, usulelo lwendlela yokuphefumla ephezulu, intloko ebuhlungu, isisu esibuhlungu, kunye norhudo kunye nezona zinto zixhaphakileyo kwilabhoratri (≥40%) kwizigulana ezinePh+ CML esanda kufunyaniswa kwi-CP. Ubalo lwe-lymphocyte luyehla, ukubalwa kwe-leukocyte, ukunciphisa i-platelet count, ukunciphisa i-neutrophil count, kunye nokunciphisa i-calcium ukulungiswa.

I-Asciminib yi-tyrosine kinase inhibitor (TKI). Ivimbela umsebenzi we-ABL1 kinase we-BCR-ABL1 iprotheni ye-fusion esebenza njengomqhubi we-CML ukwanda kuninzi lwabantu abane-CML. Ibophelela kwipokotho ye-myristoyl yeprotheni ye-BCR-ABL1 kwaye iyitshixe kwi-conformation engasebenziyo.

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