Asciminib (Scemblix) yakatenderwa kuvarwere vakura vane vachangobva kuongororwa Philadelphia chromosome-positive chisingaperi myeloid leukemia (Ph + CML) muchikamu chisingaperi (CP). Mvumo yakakurumidza yakapihwa ne FDA musi we29 October 2024.
Pakutanga, asciminib yakabvumidzwa neFDA muna Gumiguru 2021 uye ne EMA muna Nyamavhuvhu 2022 yekurapwa kwevakuru vane Ph+ CML muchikamu chisingaperi (CML-CP), yakamborapwa ne ≥ 2 TKIs, uye kurapwa kwevakuru vane Ph+ CML-CP neT315I mutation.
Mushonga uyu waive pasi pekuyedzwa kwekiriniki kuti uongorore kushanda kwayo uye kuchengetedzeka mumutsara wekutanga, gare gare-mutsara uye varwere vevana vane CML.
Kubvumidzwa kutsva kwevachangobva kuwanikwa vane CML kwakavakirwa pakuita uye kuchengetedza data kubva mukuyedzwa. Kubudirira kweasciminib kune ichangobva kuongororwa Ph + CML muCP yakaongororwa muASC4FIRST (NCT04971226) muedzo umo varwere ve405 vakanga vakarongeka (1: 1) kuti vagamuchire asciminib kana muongorori-akasarudzwa tyrosine kinase inhibitors (IS-TKIs). Chiyero chikuru chekugadzirisa chiyero chaive chikuru chemolecular response (MMR) chiyero pamavhiki e48. Maitiro akajairika akajairika (≥20%) aive kurwadziwa kwemusculoskeletal, kuputika, kuneta, hutachiona hwepamusoro hwekufema, kutemwa nemusoro, kurwadziwa mudumbu, uye manyoka uye zvinowanzoitika murabhoritari abnormalities (≥40%) muvarwere vachangobva kuongororwa Ph+ CML muCP. Yakaderera lymphocyte count, yakaderera leukocyte count, yakaderera platelet count, yakaderera neutrophil count, uye yakaderera calcium yakagadziriswa.
Asciminib inonzi tyrosine kinase inhibitor (TKI). Inodzivisa ABL1 kinase chiitiko cheBCR-ABL1 fusion protein iyo inoshanda semutyairi weCML kuwanda muruzhinji rwevanhu vane CML. Inosunga pahomwe yemyristoyl yeBCR-ABL1 protein uye inoivharira kuita isingaite conformation.
***
References:
- Press kuburitswa - FDA inopa kukurumidza kubvumidzwa kune asciminib kune ichangobva kuwanikwa isingaperi myeloid leukemia. Yakatumirwa 29 Gumiguru 2024. Inowanikwa pa https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-asciminib-newly-diagnosed-chronic-myeloid-leukemia
- Deeks, ED Asciminib: Kutanga Kubvumirwa. Zvinodhaka 82, 219–226 (2022). DOI: https://doi.org/10.1007/s40265-021-01662-3
***
