LET THE DATA LEAD YOU TO ICLUSIG
*Approved under accelerated approval. Please see full Indications and Usage.
ICLUSIG [ponatinib] for Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) and Chronic-Phase Chronic Myeloid Leukemia (CP-CML)
The path to maximize efficacy and manage tolerability
In both indications, ICLUSIG (ponatinib) uses optimized dosing† to help with dose modification upon clinical benefit.1,2
†In resistant/intolerant CP-CML: 45 mg QD → 15 mg QD upon achievement of ≤1% BCR::ABL1IS. In newly diagnosed Ph+ ALL in combination with chemotherapy: 30 mg QD → 15 mg QD upon achievement of MRD-negative (≤0.01% BCR::ABL1/ABL1) CR at the end of induction.
A starting dose of 45 mg can be reduced to 15 mg once patients achieve ≤1% BCR::ABL1IS.1
Learn about CML optimized dosing
In CML, a starting dose of 45 mg can be reduced to 15 mg once patients achieve ≤1% BCR::ABL11IS.
Learn about newly diagnosed Ph+ ALL optimized dosing
In Ph+ ALL, a starting dose of 30 mg can be reduced to 15 mg once patients achieve a meaningful response
ICLUSIG (ponatinib) is an FDA-approved TKI for adult patients with1:
- Newly diagnosed Ph+ ALL in combination with chemotherapy*
- As monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL
- CP-CML with resistance or intolerance to at least 2 prior TKIs
- AP- or BP-CML for whom no other kinase inhibitors are indicated
- T315I-positive CML (CP, AP, or BP)
Limitations of use: ICLUSIG is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.
*This indication is approved under accelerated approval based on MRD-negative CR at the end of induction. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).
AP-CML=accelerated-phase chronic myeloid leukemia; BP-CML=blast-phase chronic myeloid leukemia; CML=chronic myeloid leukemia; CP-CML=chronic-phase chronic myeloid leukemia; CR=complete remission; MRD=minimal residual disease; NCCN=National Comprehensive Cancer Network® (NCCN®); Ph+ ALL=Philadelphia chromosome-positive acute lymphoblastic leukemia; TKI=tyrosine kinase inhibitor.