Ponatinib

(Iclusig®)

Ponatinib

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Drug updated on 4/15/2024

Dosage FormTablet (oral; 10 mg, 15 mg, 30 mg, 45 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL):
  • Indicated for Newly diagnosed Ph+ ALL, in combination with chemotherapy. (1) This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).
  • Indicated as monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL.
  • Indicated for the treatment of adult patients with Chronic Myeloid Leukemia (CML):
  • Indicated for Chronic phase (CP) CML with resistance or intolerance to at least two prior kinase inhibitors.
  • Indicated for T315I-positive CML (chronic phase, accelerated phase, or blast phase).

Summary
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  • Ponatinib (Iclusig) is used for the treatment of chronic phase (CP) chronic myeloid leukemia (CML), accelerated phase or blast phase CML, Philadelphia chromosome-positive acute lymphoblastic leukemia, and T315I-positive CML in adult patients who have resistance or intolerance to at least two prior kinase inhibitors.
  • The information provided was derived from five systematic reviews/meta-analyses that compared the efficacy and safety of ponatinib against other tyrosine kinase inhibitors for treating various conditions, including CML.
  • In terms of effectiveness, ponatinib showed a Major Molecular Response rate between 19.0%-66.7% and a Complete Cytogenetic Response rate of 21.4%-64.8% at six months in CP-CML patients previously treated with ≥2 TKIs. This compares favorably to other drugs like asciminib, omacetaxine, bosutinib, especially when administered at higher doses such as 45mg.
  • While higher doses may be more effective, they are also associated with significantly higher serious adverse events and arterial occlusion events, which indicates a need for cautious use among certain patient populations.
  • Compared to dasatinib, which has high incidences of hematological toxicities such as anemia, leukopenia, ponatinib's specific safety concerns are more vascular in nature, whereas nilotinib demonstrated a safer hematological profile than both dasatinib and ponatinib, highlighting its selectivity and reduced blood cell line toxicity.
  • Lastly, regarding population types and subgroup considerations: Ponatinib's utility spans across different phases of CML and includes subgroups with the T315I mutation, showcasing its broad application spectrum within the CML treatment paradigm. However, studies suggest that ponatinib's efficacy and safety profile may necessitate individualized consideration based on patient-specific factors like disease state, previous treatment responses, mutational status, and comorbid conditions.

Product Monograph / Prescribing Information

Document TitleYearSource
Iclusig (ponatinib) Prescribing Information.2024Takeda Pharmaceuticals America Inc., Lexington, MA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines