Asciminib (Scemblix) tau pom zoo rau cov neeg mob laus uas tau kuaj pom tshiab Philadelphia chromosome-positive chronic myeloid leukemia (Ph + CML) nyob rau theem mob (CP). Qhov kev pom zoo nrawm tau tso cai los ntawm cov FDA nyob rau 29 Kaum Hlis 2024.
Ua ntej, asciminib tau pom zoo los ntawm FDA thaum Lub Kaum Hli 2021 thiab los ntawm EMA Thaum Lub Yim Hli 2022 rau kev kho cov neeg laus nrog Ph + CML nyob rau theem mob ntev (CML-CP), yav tas los kho nrog ≥ 2 TKIs, thiab rau kev kho cov neeg laus nrog Ph + CML-CP nrog T315I kev hloov.
Cov tshuaj tau nyob rau hauv kev sim tshuaj ntsuam xyuas nws cov kev ua tau zoo thiab kev nyab xeeb hauv thawj kab, kab tom qab thiab cov neeg mob menyuam yaus nrog CML.
Qhov kev pom zoo tshiab rau cov neeg kuaj mob tshiab nrog CML yog raws li cov ntaub ntawv ua tau zoo thiab kev nyab xeeb los ntawm kev sim. Kev ua tau zoo ntawm asciminib rau kev kuaj mob tshiab Ph + CML hauv CP tau raug tshuaj xyuas hauv ASC4FIRST (NCT04971226) sim uas 405 tus neeg mob tau randomized (1: 1) kom tau txais asciminib lossis cov neeg tshawb xyuas xaiv tyrosine kinase inhibitors (IS-TKIs). Qhov txiaj ntsig tseem ceeb ntawm qhov ntsuas tau yog qhov loj ntawm cov lus teb (MMR) ntawm 48 lub lis piam. Feem ntau cov kev phiv tshwm sim (≥20%) yog mob musculoskeletal, ua pob liab vog, qaug zog, kab mob ua pa sab sauv, mob taub hau, mob plab, thiab raws plab thiab feem ntau kuaj mob txawv txav (≥40%) hauv cov neeg mob uas tau kuaj pom tshiab Ph + CML hauv CP. tau txo cov lymphocyte suav, txo leukocyte suav, txo platelet suav, txo qis neutrophil suav, thiab txo calcium kho.
Asciminib yog tyrosine kinase inhibitor (TKI). Nws inhibits ABL1 kinase kev ua ntawm BCR-ABL1 fusion protein uas ua haujlwm ua tus tsav tsheb ntawm CML proliferation hauv feem ntau ntawm cov neeg uas muaj CML. Nws khi ntawm myristoyl hnab tshos ntawm BCR-ABL1 protein thiab xauv nws mus rau hauv ib qho kev tsis sib haum xeeb.
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References:
- Kev Tshaj Tawm - FDA tso cai nrawm pom zoo rau asciminib rau kev kuaj mob tshiab myeloid leukemia. Tshaj tawm 29 Lub Kaum Hli 2024. Muaj nyob ntawm https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-asciminib-newly-diagnosed-chronic-myeloid-leukemia
- Deeks, ED Asciminib: Thawj Pom Zoo. Tshuaj 82, 219–226 (2022). DOI: https://doi.org/10.1007/s40265-021-01662-3
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 has been approved for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). The accelerated approval was granted by the FDA on 29 October 2024.){kind=link}