High-Risk HR+, HER2− Early Breast Cancer: Risk of Recurrence, Trial Endpoints, and AE Management
MMAT-03262; MMAT-04239; MMAT-05184; CMAT-35084; MMAT-05258; TO28052026; VV-MED-183259; CMAT-38798
An overall survival (OS) benefit that was statistically significant was observed in the ITT population. Following consultation with regulatory authorities at the primary IDFS analysis, the OS analysis plan was modified to increase the number of final events from 390 to 650 in order to ensure a follow-up of at least 5 years. Abemciclib is approved for Cohort 1 (91% of the ITT population); the OS analysis in this subpopulation was not powered for statistical significance or alpha error control.
MMAT-03301; MMAT-04235; MMAT-05185; CMAT-35070; MMAT-05256; TO28052026; VV-MED-183257; CMAT-38793
MMAT-03302; MMAT-04237; MMAT-05187; CMAT-35082; MMAT-05257; TO28052026; VV-MED-183258; CMAT-38795
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MMAT-05418; MMAT-06323; MMAT-06405; CMAT-40602; MMAT-07072; TO1072026; CMAT-42219
July 2026
The content on this platform is available in multiple countries. Brand names and labels may differ by geography. Please refer to your local label and guidelines.
Brazil: Material destinado exclusivamente a profissionais da saúde prescritores e dispensadores de medicamentos.
Switzerland:
- *Swiss label only for Cohort 1: ≥ 4 positive axillary lymph nodes or 1–3 positive axillary lymph nodes and tumors that were ≥ 5 cm, histological Grade 3, or both. In Cohort 1, 0.6% of patients were male. The male population was excluded for the Swiss approval.*1,2
- Toi, M., et al. (2022). ‘Adjuvant Abemaciclib Combined with Endocrine Therapy: Efficacy Results in monarchE Cohort 1.’ The Oncologist 28(1): e77–e81.
- Abemaciclib Summary of Product Characteristics. www.swissmedicinfo.ch
- Health Care Professionals can request the references from the company at any time.
- Abemaciclib Summary of Product Characteristics. Available at: www.swissmedicinfo.ch
Canada: Eli Lilly Canada Inc. PrVERZENIOÒ Product Monograph. July 24, 2025
Spain: An overall survival (OS) benefit that was statistically significant was observed in the ITT population. Following consultation with regulatory authorities at the primary IDFS analysis, the OS analysis plan was modified to increase the number of final events from 390 to 650 in order to ensure a follow-up of at least 5 years. Verzenios® is approved for Cohort 1 (91% of the ITT population); the OS analysis in this subpopulation was not powered for statistical significance or alpha error control.
Gulf countries:
- UAE approved label: english physician information & english-arabic patient information.pdf
- Kuwait approved label: english physician information & english-arabic patient information.pdf
- Qatar approved label: english physician information & english-arabic patient information.pdf
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