November 20, 2025
Human medicines European public assessment report (EPAR): Iclusig, ponatinib, Date of authorisation: 01/07/2013, Revision: 27, Status: Authorised
IntelME Verdict
Treatment Advancement
TL;DR
European Medicines Agency updated EPAR for Iclusig (ponatinib) on 12 November 2025, reflecting ongoing safety and efficacy data, dose optimization, and its efficacy against the T315I mutation.
Analysis
The updated EPAR for Iclusig (ponatinib) signifies a treatment advancement for adults with specific types of leukaemia, offering a viable option for those resistant or intolerant to other tyrosine kinase inhibitors. The inclusion of dose optimization and efficacy against the T315I mutation provides clinicians with valuable insights for personalized treatment strategies.
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