I-Asciminib (Scemblix) igunyazwe ezigulini zabantu abadala ezisanda kutholwa i-Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) esigabeni esingamahlalakhona (CP). Imvume esheshisiwe inikezwe ngabakwa FDA ngo-29 October 2024.
Phambilini, i-asciminib yagunyazwa yi-FDA ngo-Okthoba 2021 nango- EMA ngo-Agasti 2022 ukuze zelashwe abantu abadala abane-Ph+ CML esigabeni esingapheli (CML-CP), abalashwe ngaphambilini nge-≥ 2 TKIs, kanye nokwelashwa kwabantu abadala abane-Ph+ CML-CP ngokuguqulwa kwe-T315I.
Umuthi wawungaphansi kokuhlolwa komtholampilo ukuze kuhlolwe ukusebenza kwawo nokuphepha emgqeni wokuqala, iziguli ezilandela kamuva kanye neziguli ezine-CML.
Ukugunyazwa okusha kwabantu abasanda kutholwa abane-CML kusekelwe ekusebenzeni kahle nedatha yokuphepha evela ocwaningweni. Ukusebenza kwe-asciminib ye-Ph+ CML esanda kutholwa ku-CP kwahlolwa esivivinyweni se-ASC4FIRST (NCT04971226) lapho iziguli ezingama-405 zahlelwa ngokungahleliwe (1:1) ukuze zithole i-asciminib noma i-tyrosine kinase inhibitors (IS-TKIs) ekhethwe ngumphenyi. Isilinganiso esiyinhloko somphumela wokuphumelela kwakuyisilinganiso esikhulu sokuphendula kwamangqamuzana (MMR) kumaviki angu-48. Ukusabela okungekuhle okuvame kakhulu (≥20%) kwakuwubuhlungu bemisipha namathambo, ukuqubuka, ukukhathala, ukutheleleka komgudu wokuphefumula ongenhla, ikhanda elibuhlungu, ubuhlungu besisu, nesifo sohudo kanye nokungajwayelekile okuvame kakhulu elabhorethri (≥40%) ezigulini ezisanda kutholwa i-Ph+ CML ku-CP. Ukuncipha kwenani le-lymphocyte, isibalo se-leukocyte sehla, isibalo se-platelet sehla, isibalo se-neutrophil sehla, nokuncipha kwe-calcium kulungiswe.
I-Asciminib iyi-tyrosine kinase inhibitor (TKI). Ivimbela umsebenzi we-ABL1 kinase we-BCR-ABL1 fusion protein esebenza njengomshayeli wokusabalala kwe-CML kuningi labantu abane-CML. Ibophezela ephaketheni le-myristoyl lephrotheni ye-BCR-ABL1 futhi iyikhiyele ekuhlanganeni okungasebenzi.
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References:
- Ukukhishwa kwabezindaba - I-FDA inikezela ukugunyazwa okusheshayo kwe-asciminib ye-myeloid leukemia esanda kutholwa. Kuthunyelwe ngomhla ka-29 Okthoba 2024. Itholakala e- https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-asciminib-newly-diagnosed-chronic-myeloid-leukemia
- Deeks, ED Asciminib: Ukuvunyelwa Kokuqala. Izidakamizwa 82, 219–226 (2022). I-DOI: https://doi.org/10.1007/s40265-021-01662-3
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