Drug updated on 12/11/2024
| Dosage Form | Tablet (oral; 10 mg, 15 mg, 30 mg, 45 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with newly diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL), in combination with chemotherapy
- Indicated as monotherapy in Ph+ ALL adult patients for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL
- Indicated for the treatment of adult patients with Chronic phase (CP) Chronic Myeloid Leukemia (CML), with resistance or intolerance to at least two prior kinase inhibitors
- Indicated for the treatment of adult patients with Accelerated phase (AP) or blast phase (BP) CML for whom no other kinase inhibitors are indicated
- Indicated for for the treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase).
Latest News
Summary
- This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-8]
- In chronic phase-chronic myeloid leukemia (CP-CML) patients with prior exposure to ≥2 tyrosine kinase inhibitors (TKIs), ponatinib achieved major molecular response (MMR) rates between 19.0-66.7%, compared to asciminib (23.3-25.5%), omacetaxine (19.2%), and bosutinib (13.2%) over 6 months.
- Complete cytogenetic response (CCyR) rates for ponatinib ranged from 21.4-64.8%, with asciminib at 38.7-40.8%, bosutinib at 18-24.2%, and omacetaxine at 16.1% after 6 months. Ponatinib 45 mg was superior in CCyR, major cytogenetic response (MCyR), and complete hematologic response (CHR) relative to lower doses and other TKIs.
- In philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), next-generation TKIs, including ponatinib, achieved a complete molecular remission (CMR) rate of 82% versus 53% with imatinib, and improved survival in nontransplant patients to levels comparable to allogeneic hematopoietic stem cell transplant (allo-HSCT) in measurable residual disease (MRD)-negative patients.
- Ponatinib presents a high risk of arterial occlusion events in patients with CML and has a significantly increased incidence of severe adverse events compared to other treatment regimens.
- Among second- and third-generation TKIs, ponatinib exhibits the highest risk of hypertension (17% incidence) and is associated with elevated risks of hepatotoxicity, particularly high-grade elevations in alanine transaminase (ALT) and aspartate transaminase (AST) levels, as well as increased occurrences of cardiovascular events, thrombocytopenia, pancreatic, and hepatic adverse effects relative to imatinib.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Iclusig (ponatinib) Prescribing Information. | 2024 | Takeda Pharmaceuticals U.S.A., Inc., Lexington, MA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| ESMO Clinical Practice Guideline interim update on the use of targeted therapy in acute lymphoblastic leukaemia | 2024 | Annals of Oncology |
| Practical Recommendations for the Manipulation of Kinase Inhibitor Formulations to Age-Appropriate Dosage Forms | 2022 | Pharmaceutics |
| Acute Lymphoblastic Leukemia, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology | 2021 | Journal of the National Comprehensive Cancer Network |
| Chronic Myeloid Leukemia, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology | 2020 | Journal of the National Comprehensive Cancer Network |
| A British Society for Haematology Guideline on the diagnosis and management of chronic myeloid leukaemia | 2020 | British Journal of Haematology |
| Ponatinib in the Treatment of Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Leukemia: Recommendations of a German Expert Consensus Panel with Focus on Cardiovascular Management | 2020 | Acta Haematologica |