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.
Share:
