The FIRST and ONLY FDA-approved TKI 
for adults with NEWLY DIAGNOSED Ph+ ALL, 
in combination with chemotherapy1*

ICLUSIG (ponatinib) for CP-CML

The path to maximizing benefit and mitigating risk2

Pill bottle.

A starting dose of 45 mg can be reduced to 15 mg once patients achieve ≤1% BCR::ABL1IS.1

Category 2A, preferred NCCN recommendation.

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.