Iclusig FDA Approval History
Last updated by Judith Stewart, BPharm on March 19, 2024.
FDA Approved: Yes (First approved December 14, 2012)
Brand name: Iclusig
Generic name: ponatinib
Dosage form: Tablets
Company: Takeda Pharmaceutical Company Limited
Treatment for: Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia
Iclusig (ponatinib) is a kinase inhibitor used for the treatment of acute lymphoblastic leukemia and chronic myeloid leukemia.
- Iclusig is indicated for the treatment of adult patients with:
- Newly diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (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).
- As monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL.
- Chronic phase Chronic Myeloid Leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors.
- Accelerated phase or blast phase CML for whom no other kinase inhibitors are indicated.
- T315I-positive CML (chronic phase, accelerated phase, or blast phase).
Limitations of Use: Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed chronic phase CML. - Iclusig tablets are administered orally once daily.
- Common adverse reactions when used as a single agent include rash and related conditions, arthralgia, abdominal pain, headache, constipation, dry skin, hypertension, fatigue, fluid retention and edema, pyrexia, nausea, pancreatitis/lipase elevation, hemorrhage, anemia, hepatic dysfunction and AOEs.
Common Grade 3 or 4 laboratory abnormalities include decreased platelet count, decreased neutrophil cell count, and decreased white blood cell count.
Development timeline for Iclusig
Further information
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