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Ponatinib is the only BCR::ABL1 inhibitor that covers the T315I resistance mutation. In 2024 it became the preferred pill for newly diagnosed Ph-positive ALL.
PhALLCON (n=245): ponatinib vs imatinib with reduced-intensity chemotherapy in newly diagnosed Ph+ ALL, MRD-negative CR at end of induction 34.4% vs 16.7%; accelerated approval March 2024. Also approved in CML (T315I and resistant disease) since 2012, with a 2013 temporary market suspension for arterial occlusive events that led to dose-reduction strategies (OPTIC). Ponatinib + blinatumomab chemotherapy-free regimens (MD Anderson) report near-universal molecular remission without transplant.
Type II TKI binding inactive ABL1 with a carbon-carbon triple bond that accommodates the T315I gatekeeper; also inhibits FGFR, VEGFR, SRC. Connects to BCR::ABL1 (Philadelphia chromosome) and ABL1.
1.Ponatinib binds the ATP pocket of BCR::ABL1, including T315I mutants
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. T315I mutation or failure/intolerance of two prior TKIs, per the label.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE TA451 · SMC advice: ponatinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Adults with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia resistant or intolerant to TKI therapy or or Philadelphia chromosome positive acute lymphoblastic leukemia resistant or intolerant to prior TKI therapy
Resistant CML/Ph+ ALL
Temporary marketing suspension for arterial occlusion; returned with narrowed label December 2013
Adults with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia resistant or intolerant to TKI therapy or or Philadelphia chromosome positive acute lymphoblastic leukemia resistant or intolerant to prior TKI therapy
Confirmed: the accelerated approval of 2012 converted to traditional approval 4.0 years after it was granted.
Adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.
Frontline Ph+ ALL (PhALLCON), accelerated The confirmatory requirement was still open 2.5 years later, when the FDA's table was read.
| Region | Year | Indication |
|---|---|---|
| US | 2012 | CML and Ph+ ALL resistant to prior TKIs or with T315I |
| US | 2024 | Newly diagnosed Ph+ ALL with chemotherapy (accelerated) |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Arterial occlusive events CML long-term data at 45 mg; lower with response-based dose reduction | 26% | - |
| Hypertension | 68% | - |
| Pancreatitis / lipase elevation | 40% | - |
| Hepatotoxicity Boxed warning | - | - |
Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
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Query for this drug: (TITLE:"Ponatinib" OR ABSTRACT:"Ponatinib" OR TITLE:"Iclusig" OR ABSTRACT:"Iclusig") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Ponatinib, not a curated reading list.
Shares BCR::ABL1 T315I, ABL1, Ph-positive ALL, BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR).
Shares BCR::ABL1 TKI + blinatumomab (chemotherapy-free Ph+ ALL), ABL1, Ph-positive ALL, Transplant-free Ph-positive ALL for MRD-negative adults.
Shares BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR), BCR::ABL1 kinase domain mutations (T315I and others), BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (KEGG map).
Shares BCR::ABL1 TKI + blinatumomab (chemotherapy-free Ph+ ALL), Ph-positive ALL, Transplant-free Ph-positive ALL for MRD-negative adults, Philadelphia chromosome-positive acute lymphoblastic leukaemia in children (Ph-positive ALL).
Shares BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR), BCR::ABL1 kinase domain mutations (T315I and others), BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (KEGG map).
Shares Chronic myeloid leukaemia, chronic phase, Chronic myeloid leukaemia, accelerated and blast phase, BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (CML).
Shares BCR::ABL1 kinase domain mutations (T315I and others), Philadelphia chromosome (Ph+, BCR::ABL1), Chronic myeloid leukaemia, chronic phase, Chronic myeloid leukaemia (CML).
Shares BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR), BCR::ABL1 kinase domain mutations (T315I and others), Philadelphia chromosome (Ph+, BCR::ABL1), Chronic myeloid leukaemia, chronic phase.