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Guidelines

Highest rated CDK4/6i in EBC

Currently the only CDK4/6i scored “A” by ESMO-MCBS for HR+/HER2– EBC (1,2)

Natalee
A
AT
Substantial benefit

Curative intent  
Evaluated outcome:

DFS, OS or pCR

Adapted from ESMO Scorecards. 2026.(1,2)

* In EBC: Grade A: Improvements in DFS alone (primary endpoint) HR ≤0.65 AND absolute gain ≥3% in studies without mature survival data.(3)

ESMO-MCBS scores are based on peer-reviewed clinical trial reports. They are generated using a validated standard methodology and are reviewed by a team of clinicians and statisticians before publication. The ESMO-MCBS facilitates clinical decision-making by rating clinically meaningful benefit of cancer medicines from published data. ESMO-MCBS scores should be interpreted in the context of an evolving treatment landscape, in connection with clinical practice guidelines.(3,4)

NCCN consensus

NCCN® recommends KISQALI + NSAI as a Category 1 preferred treatment option in both HR+/HER2– ABC and EBC. (1)

In EBC:
The first and only CDK4/6i for N0 high-risk* and N+ EBC(1)
In ABC:
The only CDK4/6i with a Category 1 rating in combination with both AI or fulvestrant(1)

* N0, T3–4 disease or N0, T2 Grade 3 or Grade 2 disease with additional risk factors, such as Ki-67 score ≥20% or defined as an Oncotype DX Breast Recurrence Score of ≥26, or Prosigna/PAM50, MammaPrint, or EndoPredictEPclinhigh-risk scores.(2)

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 

By Novartis AG

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