Asciminib (Scemblix) e amohetsoe ho bakuli ba baholo ba sa tsoa fumanoa ba Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). Tumello e potlakileng e ile ea fanoa ke ba FDA ka 29 October 2024.
Pejana, asciminib e ile ea amoheloa ke FDA ka Mphalane 2021 le ka EMA ka August 2022 bakeng sa phekolo ea batho ba baholo ba nang le Ph + CML ka nako e sa foleng (CML-CP), e kileng ea tšoaroa ka ≥ 2 TKIs, le bakeng sa phekolo ea batho ba baholo ba nang le Ph + CML-CP le phetoho ea T315I.
Setlhare se ne se le tlas'a teko ea bongaka bakeng sa ho lekola katleho ea sona le polokeho moleng oa pele, bakuli ba morao-rao le ba bana ba nang le CML.
Tumello e ncha bakeng sa batho ba sa tsoa fumanoa ba e-na le CML e ipapisitse le lintlha tsa ts'ireletso le ts'ireletso ho tsoa tekong. Ho sebetsa ha asciminib bakeng sa Ph + CML e sa tsoa fumanoa ho CP ho ile ha hlahlojoa tekong ea ASC4FIRST (NCT04971226) moo bakuli ba 405 ba neng ba sa lebelloa (1: 1) ho amohela asciminib kapa mofuputsi-khetho ea tyrosine kinase inhibitors (IS-TKIs). Tekanyo e ka sehloohong ea phello ea katleho e ne e le tekanyo e kholo ea molek'hule (MMR) libeke tsa 48. Litlamorao tse mpe tse atileng haholo (≥20%) e ne e le bohloko ba mesifa, lekhopho, mokhathala, ts'oaetso ea phefumoloho e kaholimo, hlooho, bohloko ba ka mpeng le lets'ollo le bofokoli bo atileng haholo ba laboratori (≥40%) ho bakuli ba sa tsoa fumanoa Ph+ CML ho CP. palo ea li-lymphocyte e fokotsehile, palo ea leukocyte e fokotsehile, palo ea liplatelete e fokotsehile, palo ea neutrophil e fokotsehile, 'me khalsiamo e fokotsehile.
Asciminib ke tyrosine kinase inhibitor (TKI). E thibela tšebetso ea ABL1 kinase ea BCR-ABL1 fusion protein e sebetsang e le mokhanni oa ho ata ha CML ho bongata ba batho ba nang le CML. E tlama ka pokothong ea myristoyl ea protheine ea BCR-ABL1 ebe e e notlela hore e se ke ea sebetsa.
***
References:
- Phatlalatso ea boralitaba - FDA e fana ka tumello e potlakileng ea ho asciminib bakeng sa leukemia e sa tsoa fumanoa e sa foleng ea myeloid. E ngotsoe 29 October 2024. E fumaneha ho https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-asciminib-newly-diagnosed-chronic-myeloid-leukemia
- Deeks, ED Asciminib: Kamohelo ea Pele. Lithethefatsi 82, 219-226 (2022). DOI: https://doi.org/10.1007/s40265-021-01662-3
***
 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}