November 20, 2025

Human medicines European public assessment report (EPAR): Kisqali, ribociclib, Date of authorisation: 22/08/2017, Revision: 23, Status: Authorised

IntelME Verdict

Regulatory Update

TL;DR

EMA updated the EPAR for Kisqali, confirming its authorisation date as August 22, 2017, with Revision 23, indicating its continued approval for HR-positive, HER2-negative early breast cancer treatment.

Analysis

This regulatory update on Kisqali's EPAR signifies its continued approval for HR-positive, HER2-negative early breast cancer treatment. Medical professionals rely on such assessments for updated information on safety and efficacy, guiding their clinical decisions in managing patients with high-risk breast cancer, potentially impacting treatment strategies and patient outcomes.