Regulatory approval

Published by the Food and Drug Administration. Approved

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).

This is written in the approval document.

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 30, 2024.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (2) BCR::ABL1 Acute Lymphoblastic Leukemia Cytarabine, Dexamethasone, Methotrexate, Ponatinib, Prednisone, Vincristine

Contributions

Date Contributor Description
2024-10-30 Van Allen lab Initial access of FDA approvals
2024-03-19 Food and Drug Administration Indication received traditional approval.