Drug updated on 9/4/2024
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 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).
Latest News
Summary
- Iclusig (ponatinib) is indicated for the treatment of adult patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL). This includes newly diagnosed Ph+ ALL, in combination with chemotherapy, 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 confirmatory trials. It is also indicated as monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or for T315I-positive Ph+ ALL. Additionally, Iclusig is indicated for the treatment of adult patients with Chronic Myeloid Leukemia (CML). This includes chronic phase (CP) CML with resistance or intolerance to at least two prior kinase inhibitors, as well as for T315I-positive CML across all phases (chronic phase, accelerated phase, or blast phase).
- This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
- Ponatinib demonstrated a major molecular response (MMR) rate ranging from 19.0% to 66.7% and a complete cytogenetic response (CCyR) rate ranging from 21.4% to 64.8% at 6 months, showing superior efficacy compared to other TKIs, particularly at a 45 mg dose.
- Asciminib exhibited an MMR rate of 23.3% to 25.5% and a CCyR rate of 38.7% to 40.8% at 6 months, while bosutinib showed lower MMR (13.2%) and CCyR (18% to 24.2%) rates at the same time point.
- NG-TKIs, including ponatinib, significantly improved major molecular response and MR4.5 at all time points and demonstrated higher overall survival (OS) at 12 months, with lower rates of CML-related death and progression compared to imatinib.
- The incidence of serious adverse events (SAEs) and arterial occlusive events (AOEs) was significantly higher with 45 mg ponatinib. Haematological toxicities, including anemia, leucopenia, neutropenia, and thrombocytopenia, were observed.
- Dasatinib had higher rates of anemia (SUCRA 90.3%), leucopenia (SUCRA 87.4%), neutropenia (SUCRA 90.6%), and thrombocytopenia (SUCRA 97.2%). In contrast, nilotinib demonstrated a safer profile with lower rates of these haematological toxicities (SUCRA ranges: 14.6% - 35.8%).
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Iclusig (ponatinib) Prescribing Information. | 2024 | Takeda Pharmaceuticals America Inc., Lexington, MA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Therapy for patients with chronic phase-chronic myeloid leukemia previously treated with ⩾2 tyrosine kinase inhibitors: a systematic literature review. | 2023 | Therapeutic Advances in Hematology |
Comparative efficacy and safety of different doses of ponatinib versus other tyrosine kinase inhibitors for the treatment of chronic myeloid leukemia: a systematic review and network meta-analysis. | 2023 | Expert Opinion on Drug Safety |
Systematic Review and Meta-Analysis of -New-Generation Tyrosine Kinase Inhibitors versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia | 2020 | Acta Haematologica |
The multi-tyrosine kinase inhibitor ponatinib for chronic myeloid leukemia: Real-world data | 2020 | European Journal of Haematology |
Haematological adverse events associated with tyrosine kinase inhibitors in chronic myeloid leukaemia: A network meta‐analysis. | 2019 | British Journal of Clinical Pharmacology |