Addendum to the German Consensus Recommendations on Ponatinib in the Treatment of Chronic Myeloid Leukemia

Acta Haematol. 2024;147(3):344-351. doi: 10.1159/000533666. Epub 2023 Oct 17.

Abstract

Background: Based on the new data from the primary analysis of the OPTIC (Optimizing Ponatinib Treatment in CP-CML) trial on dose optimization of ponatinib in patients with chronic phase (CP)-CML, the German consensus paper on ponatinib published in 2020 (Saussele S et al., Acta Haematol. 2020) has been updated in this addendum.

Summary: Focus is on the update of efficacy and safety of ponatinib, reflecting the new data set, as well as the update of the benefit-risk assessment and recommendations for ponatinib starting dose in CP-CML - provided that the decision to use ponatinib has already been made. Furthermore, based on OPTIC and additional empirical data, the expert panel collaborated to develop a decision tree for ponatinib dosing, specifically for intolerant and resistant patients. The recommendations on cardiovascular management have also been updated based on the most recent 2021 guidelines of the European Society of Cardiology (ESC) on cardiovascular disease prevention in clinical practice.

Key messages: The OPTIC data confirm the high efficacy of ponatinib in patients with CP-CML and provide the basis for individualized dose adjustment during the course of treatment.

Keywords: Cardiovascular management; Chronic myeloid leukemia; Consensus paper; Dosing regimens; Ponatinib.

Publication types

  • Review

MeSH terms

  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use
  • Cardiovascular Diseases / prevention & control
  • Consensus
  • Germany
  • Humans
  • Imidazoles* / administration & dosage
  • Imidazoles* / adverse effects
  • Imidazoles* / therapeutic use
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive* / drug therapy
  • Practice Guidelines as Topic
  • Protein Kinase Inhibitors / administration & dosage
  • Protein Kinase Inhibitors / adverse effects
  • Protein Kinase Inhibitors / therapeutic use
  • Pyridazines* / administration & dosage
  • Pyridazines* / adverse effects
  • Pyridazines* / therapeutic use

Substances

  • ponatinib
  • Pyridazines
  • Imidazoles
  • Antineoplastic Agents
  • Protein Kinase Inhibitors

Grants and funding

Medical writing assistance was provided by Gerhard Emrich and funded by Incyte Corporation.