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Abemaciclib Regimens Approved in Japan for Recurrent HR+/HER2- Breast Cancer

Jason Harris
Published: Friday, Sep 21, 2018

breast cancer
The Japanese Ministry of Health, Labor, and Welfare has approved abemaciclib (Verzenio) for the treatment of patients with hormone receptor (HR)-positive, HER2-negative unresectable or recurrent breast cancer in combination with fulvestrant (Faslodex) or an aromatase inhibitor (AI), according to a statement by Eli Lilly, the manufacturer of the CDK4/6 inhibitor.

Diarrhea frequency was greatest during the first month of treatment with abemaciclib. Thirty-two percent of patients with grade 2 to 3 diarrhea experienced this event in the first cycle of treatment, in the MONARCH 2 trial. The median time to onset of diarrhea was 6 to 8 days, and the duration ranged from 6 to 11 days. For 13% to 22% of patients, a dose reduction or omission was required for management of diarrhea. Overall, 85% of diarrhea events recovered with supportive treatment.


  1. Sledge GW, Toi M, Neven P, et al. MONARCH 2: abemaciclib in combination with fulvestrant in patients with HR+/HER2- advanced breast cancer who progressed on endocrine therapy. J Clin Oncol 35, 2017 (suppl; abstr 1000).
  2. Di Leo A, Toi M, Campone M, et al. MONARCH 3: Abemaciclib as initial therapy for patients with HR+/HER2- advanced breast cancer. Presented at: 2017 ESMO Congress; Madrid, Spain; September 8-12, 2017. Abstract 236O_PR.

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