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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
