Iclusig (ponatinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Takeda Pharmaceuticals America, Inc. Iclusig (ponatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203469s037lbl.pdf. Revised March 2024. Accessed October 6, 2026.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
ICLUSIG is a kinase inhibitor indicated for the treatment of adult patients with newly diagnosed Ph+ ALL, in combination with chemotherapy. 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). 1
ICLUSIG is a kinase inhibitor indicated for the treatment of adult patients with as monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL. 1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (1) BCR::ABL1 Acute Lymphoblastic Leukemia Cytarabine, Dexamethasone, Methotrexate, Ponatinib, Prednisone, Vincristine
FDA (1) ABL1 p.T315I, BCR::ABL1 Acute Lymphoblastic Leukemia Ponatinib