The EMA Assessment of Asciminib for the Treatment of Adult Patients With Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase Who Were Previously Treated With at Least Two Tyrosine Kinase Inhibitors

C. Mircea S. Tesileanu, Sotirios Michaleas, Rocio Gonzalo Ruiz, Segundo Mariz, Babs O. Fabriek, Paula B. Van Hennik, Jutta Dedorath, Bruna Dekic, Christoph Unkrig, Andreas Brandt, Janet Koenig, Harald Enzmann, Julio Delgado, Francesco Pignatti*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Asciminib is an allosteric high-affinity tyrosine kinase inhibitor (TKI) of the BCR-ABL1 protein kinase. This kinase is translated from the Philadelphia chromosome in chronic myeloid leukemia (CML). Marketing authorization for asciminib was granted on August 25, 2022 by the European Commission. The approved indication was for patients with Philadelphia chromosome-positive CML in the chronic phase which have previously been treated with at least 2 TKIs. Clinical efficacy and safety of asciminib were evaluated in the open-label, randomized, phase III ASCEMBL study. The primary endpoint of this trial was major molecular response (MMR) rate at 24 weeks. A significant difference in MRR rate was shown between the asciminib treated population and the bosutinib control group (25.5% vs. 13.2%, respectively, P=.029). In the asciminib cohort, adverse reactions of at least grade 3 with an incidence≥5% were thrombocytopenia, neutropenia, increased pancreatic enzymes, hypertension, and anemia. The aim of this article is to summarize the scientific review of the application which led to the positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use.

Original languageEnglish
Pages (from-to)628-632
Number of pages5
JournalOncologist
Volume28
Issue number7
DOIs
Publication statusPublished - Jul 2023

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© 2023 The Author(s). Published by Oxford University Press.

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