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 updates EPAR for Kisqali, confirming its authorisation date, status, and indication for early breast cancer treatment, highlighting ongoing regulatory oversight and established efficacy.
Analysis
The EMA's updated EPAR for Kisqali signifies continued authorization and established efficacy in treating early breast cancer. For biotech/pharma professionals, this reaffirms regulatory compliance, ongoing safety monitoring, and the drug's recognized benefit in combination therapy, providing valuable guidance for further development and market positioning.
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