An yarda da Asciminib (Scemblix) ga marasa lafiya marasa lafiya tare da sabon bincike na Philadelphia chromosome-positive myeloid leukemia (Ph + CML) a cikin lokaci na yau da kullum (CP). An ba da izinin gaggawa ta hanyar FDA a kan 29 Oktoba 2024.
Tun da farko, FDA ta amince da asciminib a cikin Oktoba 2021 kuma ta Ema a watan Agusta 2022 don kula da manya tare da Ph+ CML a cikin lokaci na yau da kullun (CML-CP), wanda aka bi da shi a baya tare da ≥ 2 TKIs, da kuma kula da manya tare da Ph+ CML-CP tare da maye gurbin T315I.
Magungunan yana ƙarƙashin gwaji na asibiti don kimanta ingancinsa da aminci a layin farko, layi na baya da kuma marasa lafiya na yara tare da CML.
Sabuwar yarda ga sabbin mutanen da aka gano tare da CML ta dogara ne akan inganci da bayanan aminci daga gwaji. An kimanta ingancin asciminib don sabon binciken Ph + CML a cikin CP a cikin gwajin ASC4FIRST (NCT04971226) wanda aka bazuwar marasa lafiya 405 (1: 1) don karɓar ko dai asciminib ko masu hana tyrosine kinase masu bincike (IS-TKIs). Babban ma'aunin sakamako na inganci shine babban ƙimar amsawar kwayoyin halitta (MMR) a makonni 48. Abubuwan da suka fi dacewa (≥20%) sune zafi na musculoskeletal, rash, gajiya, kamuwa da cuta na numfashi na sama, ciwon kai, ciwon ciki, da gudawa da kuma rashin daidaituwa na dakin gwaje-gwaje (≥40%) a cikin marasa lafiya tare da sabon binciken Ph + CML a cikin CP. an rage adadin lymphocyte, rage yawan leukocyte, rage adadin platelet, rage yawan neutrophil, da rage gyaran calcium.
Asciminib shine mai hana tyrosine kinase (TKI). Yana hana ayyukan ABL1 kinase na furotin fusion na BCR-ABL1 wanda ke aiki azaman direba na yaduwar CML a yawancin mutane tare da CML. Yana ɗaure a aljihun myristoyl na furotin BCR-ABL1 kuma yana kulle shi cikin daidaituwa mara aiki.
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References:
- Sakin latsawa - FDA ta ba da ƙarin izini don asciminib don sabon kamuwa da cutar sankarar bargo ta myeloid. An buga 29 Oktoba 2024. Akwai a https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-asciminib-newly-diagnosed-chronic-myeloid-leukemia
- Deeks, ED Asciminib: Amincewa ta Farko. Magunguna 82, 219-226 (2022). DOI: https://doi.org/10.1007/s40265-021-01662-3
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