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Iclusig is a prescription kinase inhibitor containing ponatinib. It treats selected adults with Philadelphia chromosome-positive acute lymphoblastic leukemia and chronic myeloid leukemia, including disease with the T315I mutation. It is not indicated for newly diagnosed chronic-phase CML.
read more about iclusig ...Ponatinib inhibits ABL and mutant ABL kinases, including T315I. It also inhibits several other kinases in laboratory studies. Blocking BCR-ABL signaling reduces viability of leukemia cells that depend on native or mutant BCR-ABL activity.
Iclusig is used with chemotherapy for newly diagnosed Ph-positive ALL in adults. It is also used alone for Ph-positive ALL when no other kinase inhibitor is indicated or when T315I is present, for chronic-phase CML after resistance or intolerance to at least two prior kinase inhibitors, and for selected advanced-phase or T315I-positive CML.
Newly diagnosed Ph-positive ALL starts at 30 mg once daily with chemotherapy and decreases to 15 mg after an MRD-negative complete remission at the end of induction. Ph-positive ALL monotherapy and accelerated- or blast-phase CML start at 45 mg once daily. Chronic-phase CML starts at 45 mg once daily and decreases to 15 mg after reaching the labeled BCR-ABL response threshold.
Iclusig carries boxed warnings for arterial occlusive events, venous thromboembolic events, heart failure, and liver toxicity, including fatal events. Other serious concerns include high blood pressure, pancreatitis, neuropathy, eye toxicity, hemorrhage, fluid retention, cardiac arrhythmias, myelosuppression, and fetal harm.
Iclusig treats selected adult cases of Ph-positive acute lymphoblastic leukemia and chronic myeloid leukemia.
Yes. Ponatinib inhibits T315I-mutant ABL and current labeling includes T315I-positive Ph-positive ALL and CML.
The recommended starting dose is 45 mg once daily with reduction to 15 mg after the labeled molecular response threshold is reached.
Yes. The boxed warnings cover arterial occlusive events, venous thromboembolic events, heart failure, and hepatotoxicity.
DailyMed - ICLUSIG - ponatinib hydrochloride tablet, film coated. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=16d804b6-4957-43ee-b18c-3b36ec37c5ac. Date Accessed October 2, 2026.
FDA Grants Accelerated Approval to Ponatinib With Chemotherapy for Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-ponatinib-chemotherapy-newly-diagnosed-philadelphia-chromosome. Date Accessed October 2, 2026.
ICLUSIG (Ponatinib) Accelerated Approval Letter. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203469Orig1s037ltr.pdf. Date Accessed October 2, 2026.
Ponatinib - MedlinePlus Drug Information. https://medlineplus.gov/druginfo/meds/a613029.html. Date Accessed October 2, 2026.
Ponatinib Hydrochloride - National Cancer Institute. https://www.cancer.gov/about-cancer/treatment/drugs/ponatinibhydrochloride. Date Accessed October 2, 2026.