ponatinib

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Associated Genetic Biomarkers

Associated Diseases

Overview

Generic Name(s):

ponatinib

Trade Name(s):

Iclusig

NCI Definition [1]:

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.

Biomarker-Directed Therapies

Ponatinib can be used in the treatment of acute lymphoblastic leukemia and chronic myeloid leukemia. ABL1, ABL1 T315I, and BCR are the most frequent biomarker inclusion criteria for use of ponatinib [2].

Acute Lymphoblastic Leukemia +

Disease is predicted to be sensitive to ponatinib: -

Biomarker Criteria:

Sample must match all of the following:

BCR-ABL1 Fusion, ABL1 T315I

Clinical Setting(s): Maintenance therapy (FDA, NCCN), Refractory (FDA, NCCN), Relapse (FDA, NCCN), Treatment Induction (FDA, NCCN)

Note: Indicated for T315I-positive Ph+ ALL.

Biomarker Criteria: Sample must match all of the following: BCR-ABL1 Fusion, ABL1 T315I	Clinical Setting(s): Maintenance therapy (FDA, NCCN), Refractory (FDA, NCCN), Relapse (FDA, NCCN), Treatment Induction (FDA, NCCN)
	Note: Indicated for T315I-positive Ph+ ALL.

Biomarker Criteria:

Sample must match one or more of the following:

ABL1 T315I

Clinical Setting(s): Maintenance therapy (FDA, NCCN), Refractory (FDA, NCCN), Relapse (FDA, NCCN), Treatment Induction (FDA, NCCN)

Note: Indicated for T315I-positive Ph+ ALL.

Biomarker Criteria: Sample must match one or more of the following: ABL1 T315I	Clinical Setting(s): Maintenance therapy (FDA, NCCN), Refractory (FDA, NCCN), Relapse (FDA, NCCN), Treatment Induction (FDA, NCCN)
	Note: Indicated for T315I-positive Ph+ ALL.

Biomarker Criteria:

Sample must match one or more of the following:

BCR-ABL1 Fusion

Clinical Setting(s): Maintenance therapy (FDA, NCCN), Refractory (FDA, NCCN), Relapse (FDA, NCCN), Treatment Induction (FDA, NCCN)

Note: Indicated for Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other kinase inhibitors are indicated.

Biomarker Criteria: Sample must match one or more of the following: BCR-ABL1 Fusion	Clinical Setting(s): Maintenance therapy (FDA, NCCN), Refractory (FDA, NCCN), Relapse (FDA, NCCN), Treatment Induction (FDA, NCCN)
	Note: Indicated for Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other kinase inhibitors are indicated.

Biomarker Criteria:

Sample must match all of the following:

BCR-ABL1 Fusion, ABL1 T315I

Clinical Setting(s): Refractory (NICE, BNF, SMC), Relapse (NICE, BNF, SMC), Treatment Induction (BNF)

Note: Prior multiple TKI treatment have failed.

Biomarker Criteria: Sample must match all of the following: BCR-ABL1 Fusion, ABL1 T315I	Clinical Setting(s): Refractory (NICE, BNF, SMC), Relapse (NICE, BNF, SMC), Treatment Induction (BNF)
	Note: Prior multiple TKI treatment have failed.

Chronic Myeloid Leukemia +

Disease is predicted to be sensitive to ponatinib: -

Biomarker Criteria:

Sample must match all of the following:

BCR-ABL1 Fusion, ABL1 T315I

Clinical Setting(s): Refractory (FDA, NCCN), Relapse (FDA, NCCN)

Note: Indicated for T315I-positive CML (chronic phase, accelerated phase, or blast phase).

Biomarker Criteria: Sample must match all of the following: BCR-ABL1 Fusion, ABL1 T315I	Clinical Setting(s): Refractory (FDA, NCCN), Relapse (FDA, NCCN)
	Note: Indicated for T315I-positive CML (chronic phase, accelerated phase, or blast phase).

Biomarker Criteria:

Sample must match one or more of the following:

ABL1 T315I

Clinical Setting(s): Refractory (FDA, NCCN), Relapse (FDA, NCCN)

Note: Indicated for T315I-positive CML (chronic phase, accelerated phase, or blast phase).

Biomarker Criteria: Sample must match one or more of the following: ABL1 T315I	Clinical Setting(s): Refractory (FDA, NCCN), Relapse (FDA, NCCN)
	Note: Indicated for T315I-positive CML (chronic phase, accelerated phase, or blast phase).

Biomarker Criteria:

Sample must match all of the following:

BCR-ABL1 Fusion

Clinical Setting(s): Refractory (NICE, BNF, SMC), Relapse (BNF, SMC), Treatment Induction (BNF)

Note: Applies if multiple prior TKI treatment failed.

Biomarker Criteria: Sample must match all of the following: BCR-ABL1 Fusion	Clinical Setting(s): Refractory (NICE, BNF, SMC), Relapse (BNF, SMC), Treatment Induction (BNF)
	Note: Applies if multiple prior TKI treatment failed.

Clinical Trials

View Clinical Trials for ponatinib

Ponatinib has been investigated in 30 clinical trials, of which 26 are open and 4 are closed. Of the trials investigating ponatinib, 2 are phase 1 (1 open), 6 are phase 1/phase 2 (5 open), 19 are phase 2 (18 open), 2 are phase 3 (2 open), and 1 is no phase specified (0 open).

BCR-ABL1 Fusion, t(9;22)(q34;q11), and FLT3 ITD are the most frequent biomarker inclusion criteria for ponatinib clinical trials.

Acute lymphoblastic leukemia, chronic myeloid leukemia, and acute myeloid leukemia are the most common diseases being investigated in ponatinib clinical trials [2].

Top Biomarker Inclusion Criteria for Open Clinical Trials Investigating Ponatinib

Top Biomarker Inclusion Criteria for Closed Clinical Trials Investigating Ponatinib

This graph displays the 20 most frequently occurring biomarkers curated on clinical trials investigating ponatinib and the cancer types associated with these biomarkers. These numbers are derived from a set of 5,956 clinical trials for which biomarker status defines treatment.

Drug Details

Synonyms [2]:

ap24534, Iclusig, ponatinib (product), ap-24534, ponatinib, ponatinib, 3-(2-(imidazo(1,2-b)pyridazin-3-yl)ethynyl)-4-methyl-n-(4-((4-methylpiperazin-y-1-yl)methyl)-3-(trifluoromethyl)phenyl)benzamide, ponatinibum, ponatinib (substance), benzamide, 3-(2-imidazo(1,2-b)pyridazin-3-ylethynyl)-4-methyl-n-(4-((4-methyl-1- piperazinyl)methyl)-3-(trifluoromethyl)phenyl), ap 24534

Drug Categories [2]:

ABL inhibitors, FGFR1/2/3 inhibitors, Tyrosine kinase inhibitors

Drug Target(s) [2]:

ABL1, DDR1, DDR2, FGFR1, FGFR2, FGFR3, FLT3, KDR, KIT, RET, TEK

NCIT ID [1]:

C95777

SNOMED ID [1]:

R-FBDBE

References

1. National Cancer Institute. NCI Thesaurus Version 18.11d. https://ncit.nci.nih.gov/ncitbrowser/. [2018-07-30] [2018-08-02].

2. All assertions and clinical trial landscape data are curated from primary sources. You can read more about the curation process here.

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Associated Genetic Biomarkers

Associated Diseases

Overview

Biomarker-Directed Therapies

Clinical Trials

Drug Details

References

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