October 2021: Kudya neDrug Administration kwave kubvumidza abemaciclib (Verzenio, Eli Lilly uye Kambani) pamwe chete ne endocrine therapy (tamoxifen kana aromatase inhibitor) ye adjuvant kurapwa kwevarwere vakuru vane hormone receptor (HR) -positive, human epidermal growth factor receptor 2 (HER2) -negative, node-positive, kenza yemazamu yekutanga panjodzi huru kudzokorora uye chibodzwa cheKi-67 chisingasviki makumi maviri muzana, sekutsanangurwa neFDA- Iyi ndiyo yekutanga CDK 20/4 inhibitor kubvumidzwa kurapwa kwegomarara rezamu.
Agilent, Inc. yakaendesa Ki-67 IHC MIB-1 pharmDx (Dako Omnis) assay, iyo yakabvumirwa neFDA semufambisi wekuongorora kwechiratidzo ichi.
Vakadzi vakuru nevarume vane HR-positive, HER2-negative, node-positive, resected, kenza yemazamu yekutanga ine kliniki uye pathological hunhu hunoenderana nenjodzi huru yekudzoka kwechirwere vaibatanidzwa mu monarchE (NCT03155997), a randomized (1: 1) , open-label, two-cohort multicenter muyedzo. Varwere vakapihwa angave makore maviri eabemaciclib pamwe nesarudzo yachiremba yavo yeyakajairwa endocrine mushonga kana yakajairika endocrine therapy chete.
Invasive chirwere-isina kupona yaive yekutanga mhedzisiro mhedzisiro chiyero (IDFS). Muedzo wakawana kuvandudzwa kwenhamba muIDFS (HR 0.626; 95 muzana CI: 0.488, 0.803; p = 0.0042) kune varwere vane njodzi huru yekudzoka uye Ki-67 Score isingasviki 20% (N = 2003). Varwere vaigamuchira abemaciclib ne tamoxifen kana aromatase inhibitor vaiva neIDFS ye86.1 muzana (95 muzana CI: 82.8, 88.8) mumwedzi ye36, asi avo vanogamuchira tamoxifen kana aromatase inhibitor vaiva neIDFS ye79.0 muzana (95 muzana 75.3. ) Panguva yekuongorora kweIDFS, data rese rekupona rakanga risati rakwana.
Manyoka, zvirwere, neutropenia, kuneta, leukopenia, kusvotwa, kupererwa neropa, uye kutemwa nemusoro ndizvo zvainyanya kuitika (20%).
Iyo yakakurudzirwa yekutanga dose yeabemaciclib ndeye 150 mg kaviri zuva nezuva pamwe chete netamoxifen kana aromatase inhibitor kwemakore maviri kana kusvika chirwere chekudzoka kana huturu husingaregi, chero hupi hunouya pakutanga.
