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.