Active Ingredient History
Ponatinib (trade name Iclusig, previously AP24534) is developed by ARIAD Pharmaceuticals for the treatment of chronic myeloid leukemia (CML) and Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL). Ponatinib has been designed to be effective against these types of tumors. The United States Food and Drug Administration approved the drug as a candidate in 2012, but temporarily suspended sales on 31 October 2013 because of "the risk of life-threatening blood clots and severe narrowing of blood vessels". This suspension was partially lifted on Dec. 20, 2013 with ponatinib being issued revised prescribing information, a new "Black Box Warning" and a "Risk Evaluation and Mitigation Strategy" in place to better evaluate the risks and benefits of using the drug. Ponatinib is an orally bioavailable multitargeted receptor tyrosine kinase (RTK) inhibitor with potential antiangiogenic and antineoplastic activities. Ponatinib inhibits unmutated and all mutated forms of Bcr-Abl, including T315I, the highly drug therapy-resistant missense mutation of Bcr-Abl. This agent also inhibits other tyrosine kinases including those associated with vascular endothelial growth factor receptors (VEGFRs) and fibroblast growth factor receptors (FGFRs); in addition, it inhibits the tyrosine kinase receptor TIE2 and FMS-related tyrosine kinase receptor-3 (Flt3). RTK inhibition by ponatinib may result in the inhibition of cellular proliferation and angiogenesis and may induce cell death. Bcr-Abl is a fusion tyrosine kinase encoded by the Philadelphia chromosome. NCATS
Drug Pricing (per unit)
Note: This drug pricing data is preliminary, incomplete, and may contain errors.
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Leukemia, Myeloid, Chronic-Phase (approved 2013)
Adenocarcinoma of Lung (Phase 2)
Adult (Phase 2)
Anemia (Phase 1)
Biliary Tract Neoplasms (Phase 2)
Breast Neoplasms (Phase 2)
Carcinoma, Non-Small-Cell Lung (Phase 2)
Chronic Disease (Phase 2)
Drugs, Investigational (Phase 2/Phase 3)
Drug Therapy (Phase 2)
Fusion Proteins, bcr-abl (Phase 2)
Gastrointestinal Neoplasms (Phase 2)
Gastrointestinal Stromal Tumors (Phase 2)
Glioblastoma (Phase 2)
Hematologic Neoplasms (Phase 1)
Hematopoietic Stem Cell Transplantation (Phase 2/Phase 3)
Hodgkin Disease (Phase 1)
Leukemia (Phase 2)
Leukemia, Lymphocytic, Chronic, B-Cell (Phase 2)
Leukemia, Lymphoid (Phase 3)
Leukemia, Myeloid, Accelerated Phase (Phase 1/Phase 2)
Leukemia, Myeloid, Acute (Phase 2)
Leukemia, Myeloid, Chronic-Phase (Phase 3)
Leukemia, Myelomonocytic, Chronic (Phase 2)
Lymphoma (Phase 1/Phase 2)
Lymphoma, Non-Hodgkin (Phase 1)
Multiple Myeloma (Phase 1)
Mutation (Phase 2)
Myelodysplastic Syndromes (Phase 1/Phase 2)
Myeloproliferative Disorders (Phase 1)
Neoplasm Metastasis (Phase 2)
Neoplasm, Residual (Phase 2/Phase 3)
Neoplasms (Phase 2)
Pancreatic Neoplasms (Phase 1)
Primary Myelofibrosis (Phase 1)
Small Cell Lung Carcinoma (Phase 2)
Squamous Cell Carcinoma of Head and Neck (Phase 2/Phase 3)
Thyroid Neoplasms (Phase 2)
Translocation, Genetic (Phase 2)
| Trial | Phase | Start Date | Organizations | Indications |
|---|
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