Difference between revisions of "Ponatinib (Iclusig)"

Latest revision as of 20:20, 22 March 2024

General information

Class/mechanism: Tyrosine kinase inhibitor with multiple targets, including Bcr-Abl tyrosine kinase, the constitutively active tyrosine kinase resulting from the Philadelphia chromosome abnormality in CML, as well as VEGFR, PDGFR, FGFR, the SRC kinases, KIT, EPH receptors, RET, TIE2, and FLT3. Ponatinib is active against the Bcr-Abl T315I mutation.^[1]^[2]^[3]
Route: PO
Extravasation: n/a

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.^[1]

Toxicity management

2013-10-31: Suspended by FDA because of the risk of life-threatening blood clots and severe narrowing of blood vessels.
2013-12-20: REMS program put in place and medication is once again available; REMS was discontinued in August 2018.

Diseases for which it is used

Patient drug information

History of changes in FDA indication

2012-12-14: Accelerated approval for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy (Based on OPTIC)
2012-12-14: Accelerated approval for the treatment of adult patients with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy. (Based on PACE)
2016-11-29: Granted full approval for the treatment of adult patients with chronic-phase, accelerated-phase, or blast-phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) for whom no other tyrosine kinase inhibitor therapy is indicated. (Based on PACE)
2016-11-29: Granted full approval for the treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase). (Based on PACE)
2016-11-29: Granted full approval for the treatment of adult patients with T315I-positive, Philadelphia chromosome-positive ALL. (Based on PACE)
2024-03-19: Granted accelerated approval in combination with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). (Based on PhALLCON)

History of changes in EMA indication

2013-07-01: Initial authorization

History of changes in Health Canada indication

2015-04-02: Initial notice of compliance with conditions
2022-10-03: Conditions were met

History of changes in PMDA indication

2016-09-28: New approval for the treatment of chronic myelogenous leukemia with resistance or intolerance to prior drug therapies.
2016-09-28: New approval for the treatment of recurrent or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia.

Also known as

Code name: AP-24534
Generic name: ponatinib hydrochloride
Brand name: Iclusig

References

[insert-1] 1.0 ^1.1 ^1.2 Ponatinib (Iclusig) package insert

[2] Ponatinib (Iclusig) package insert (locally hosted backup)

[3] Iclusig manufacturer's website

[4] Ponatinib (Iclusig) patient drug information (Chemocare)

[5] Ponatinib (Iclusig) patient drug information (UpToDate)

[1]

[2]

[3]

[4]

[5]

@@ Line 1: / Line 1: @@
-'''FDA approved 12/14/2012.'''  Also known as AP24534.
 ==General information==
-Class/mechanism: Tyrosine kinase inhibitor with multiple targets, including Bcr-Abl tyrosine kinase, the constitutively active tyrosine kinase resulting from the Philadelphia chromosome abnormality in CML, as well as VEGFR, PDGFR, FGFR, the SRC kinases, KIT, EPH receptors, RET, TIE2, and FLT3.  Ponatinib is active against the Bcr-Abl T315I mutation.<ref name="insert">[http://iclusig.com/pdf/FDA_Approved_PI.pdf Ponatinib (Iclusig) package insert]</ref><ref>[[Media:Ponatinib.pdf | Ponatinib (Iclusig) package insert (locally hosted backup)]]</ref><ref>[http://iclusig.com/ Iclusig manufacturer's website]</ref><ref>[http://www.ariad.com/wt/tertiarypage/AP24534 Ariad's Ponatinib (AP24534) site]</ref>
+Class/mechanism: Tyrosine kinase inhibitor with multiple targets, including Bcr-Abl tyrosine kinase, the constitutively active tyrosine kinase resulting from the Philadelphia chromosome abnormality in CML, as well as VEGFR, PDGFR, FGFR, the SRC kinases, KIT, EPH receptors, RET, TIE2, and FLT3.  Ponatinib is active against the Bcr-Abl T315I mutation.<ref name="insert">[https://www.iclusig.com/pdf/ICLUSIG-Prescribing-Information.pdf Ponatinib (Iclusig) package insert]</ref><ref>[[:File:Ponatinib.pdf | Ponatinib (Iclusig) package insert (locally hosted backup)]]</ref><ref>[http://iclusig.com/ Iclusig manufacturer's website]</ref>
 <br>Route: PO
 <br>Extravasation: n/a
-For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer.  Instead, for the most current information, please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>
+For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>
+==Toxicity management==
+*2013-10-31: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm373072.htm Suspended by FDA] because of the risk of life-threatening blood clots and severe narrowing of blood vessels.
+*2013-12-20: [http://www.iclusigrems.com/ REMS] program put in place and medication is once again available; REMS was discontinued in August 2018.
 ==Diseases for which it is used==
-*[[Chronic myelogenous leukemia]]
+*[[Chronic myeloid leukemia]]
-*Philadelphia chromosome positive [[acute lymphocytic leukemia]]
+*[[B-cell_acute_lymphoblastic_leukemia,_Ph-positive|Ph+ B-cell ALL]]
 ==Patient drug information==
-*Patient counseling information can be found on [http://iclusig.com/pdf/FDA_Approved_PI.pdf#page=16 pages 16-17 of the Ponatinib (Iclusig) package insert]<ref name="insert"></ref>
+*[https://www.iclusig.com/pdf/ICLUSIG-Prescribing-Information.pdf Ponatinib (Iclusig) package insert]<ref name="insert"></ref>
+*[https://chemocare.com/druginfo/ponatinib.aspx Ponatinib (Iclusig) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/ponatinib.aspx Ponatinib (Iclusig) patient drug information (Chemocare)]</ref>
+*[http://www.uptodate.com/contents/ponatinib-patient-drug-information Ponatinib (Iclusig) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/ponatinib-patient-drug-information Ponatinib (Iclusig) patient drug information (UpToDate)]</ref>
 ==History of changes in FDA indication==
-*12/14/2012: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332252.htm FDA approved] "for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy."
+*2012-12-14: Accelerated approval for the treatment of adult patients with chronic phase, accelerated phase, or blast phase [[Chronic myeloid leukemia|chronic myeloid leukemia (CML)]] that is resistant or intolerant to prior [[Regimen_classes#Tyrosine_kinase_inhibitor_therapy|tyrosine kinase inhibitor therapy]] ''(Based on OPTIC)''
+*2012-12-14: Accelerated approval for the treatment of adult patients with [[Biomarkers#BCR-ABL1|Philadelphia chromosome positive]] [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic leukemia]] (Ph+ ALL) that is resistant or intolerant to prior [[Regimen_classes#Tyrosine_kinase_inhibitor_therapy|tyrosine kinase inhibitor therapy]]. ''(Based on PACE)''
+*2016-11-29: Granted full approval for the treatment of adult patients with chronic-phase, accelerated-phase, or blast-phase [[Chronic myeloid leukemia | chronic myeloid leukemia (CML)]] or [[Biomarkers#BCR-ABL1|Philadelphia chromosome-positive]] [[:Category:Acute lymphoblastic leukemias| acute lymphoblastic leukemia (ALL)]] for whom no other tyrosine kinase inhibitor therapy is indicated. ''(Based on PACE)''
+*2016-11-29: Granted full approval for the treatment of adult patients with [[Biomarkers#T315I|T315I]]-positive [[Chronic myeloid leukemia|CML]] (chronic phase, accelerated phase, or blast phase). ''(Based on PACE)''
+*2016-11-29: Granted full approval for the treatment of adult patients with [[Biomarkers#T315I|T315I]]-positive, [[Biomarkers#BCR-ABL1|Philadelphia chromosome-positive]] [[:Category:Acute lymphoblastic leukemias|ALL]]. ''(Based on PACE)''
+*2024-03-19: Granted accelerated approval in combination with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome-positive [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic leukemia]] (Ph+ ALL). ''(Based on PhALLCON)''
+==History of changes in EMA indication==
+*2013-07-01: Initial authorization
+==History of changes in Health Canada indication==
+*2015-04-02: Initial notice of compliance with conditions
+*2022-10-03: Conditions were met
+==History of changes in PMDA indication==
+*2016-09-28: New approval for the treatment of [[Chronic myeloid leukemia|chronic myelogenous leukemia]] with resistance or intolerance to prior drug therapies.
+*2016-09-28: New approval for the treatment of recurrent or refractory Philadelphia chromosome-positive [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic leukemia]].
+==Also known as==
+*'''Code name:''' AP-24534
+*'''Generic name:''' ponatinib hydrochloride
+*'''Brand name:''' Iclusig
 ==References==
 <references/>
-[[Category:Drug index]]
+[[Category:Drugs]]
-[[Category:Chemotherapy]]
+[[Category:Oral medications]]
-[[Category:Tyrosine kinase inhibitors]]
+[[Category:Mutation-specific medications]]
 [[Category:Bcr-Abl inhibitors]]
-[[Category:VEGF inhibitors]]
+[[Category:FGFR inhibitors]]
+[[Category:FLT3 inhibitors]]
+[[Category:KIT inhibitors]]
+[[Category:RET inhibitors]]
+[[Category:SRC inhibitors]]
+[[Category:VEGFR inhibitors]]
 [[Category:PDGFR inhibitors]]
-[[Category:Chronic myelogenous leukemia medications]]
-[[Category:Drugs FDA approved in 2012]]
+[[Category:B-cell acute lymphoblastic leukemia medications]]
+[[Category:Chronic myeloid leukemia medications]]
+[[Category:FDA approved in 2012]]
+[[Category:EMA approved in 2013]]
+[[Category:Health Canada approved in 2015]]
+[[Category:PMDA approved in 2016]]