November 20, 2025

Human medicines European public assessment report (EPAR): Iclusig, ponatinib, Date of authorisation: 01/07/2013, Revision: 27, Status: Authorised

IntelME Verdict

R&D Advance

TL;DR

EMA updated EPAR for Iclusig (ponatinib) on 12 November 2025, highlighting its efficacy against CML and Ph+ ALL, including T315I mutation, with dose optimization.

Analysis

The updated EPAR for Iclusig (ponatinib) signifies a significant R&D advance in the field of oncology. Highlighting efficacy against CML and Ph+ ALL, including the T315I mutation, with dose optimization, this update provides valuable insights for drug developers, clinicians, and researchers working on targeted therapies for leukemia, especially in cases of resistance or intolerance to other TKIs.