Oktoba 2021: Hukumar Abinci da Magunguna ta amince abemaciclib (Verzenio, Eli Lilly da Kamfanin) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of less than 20%, as determined by an FDA- This is the first CDK 4/6 inhibitor to be approved for breast cancer adjuvant treatment.
Agilent, Inc. ya ƙaddamar da gwajin Ki-67 IHC MIB-1 pharmDx (Dako Omnis), wanda FDA ta ba da izini a matsayin abokin bincike don wannan nuni.
Manya mata da maza tare da HR-tabbatacce, HER2-negative, node-positive, resected, farkon nono ciwon daji tare da asibiti da kuma pathological halaye daidai da babban hadarin sake dawowa da cuta sun shiga cikin monarchE (NCT03155997), bazuwar (1: 1). , buɗaɗɗen lakabin, gwaji na ƙungiyoyin ƙungiya biyu. An bai wa marasa lafiya ko dai shekaru 2 na abemaciclib tare da zaɓin likitan su na daidaitaccen maganin endocrin ko na al'ada na endocrin kawai.
Rayuwa ba tare da cututtuka masu haɗari ba shine ma'aunin sakamako na farko (IDFS). Gwajin ya sami ci gaba mai mahimmanci a cikin IDFS (HR 0.626; 95 bisa dari CI: 0.488, 0.803; p = 0.0042) a cikin marasa lafiya tare da babban haɗari na sake dawowa da Ki-67 Score na kasa da 20% (N = 2003). Marasa lafiya da ke karɓar abemaciclib tare da tamoxifen ko mai hana aromatase suna da IDFS na 86.1 bisa dari (95 bisa dari CI: 82.8, 88.8) a cikin watanni 36, yayin da masu karɓar tamoxifen ko mai hana aromatase suna da IDFS na 79.0 bisa dari (95 bisa dari CI: 75.3, ). A lokacin nazarin IDFS, ba a cika cikakken bayanin rayuwa ba.
Zawo, cututtuka, neutropenia, gajiya, leukopenia, tashin zuciya, anemia, da ciwon kai sune mafi yawan illa (20%).
Shawarar da aka ba da shawarar farawa na abemaciclib shine 150 MG sau biyu kowace rana a hade tare da tamoxifen ko mai hana aromatase na shekaru 2 ko har sai cutar ta sake dawowa ko rashin iya jurewa, duk wanda ya fara zuwa.
