Iclusig® (Ponatinib) - Chronic Myeloid Leukemia - CML
"Ponatinib (trade name Iclusig /aɪˈkluːsɪɡ/ eye-KLOO-sig, previously AP24534) is an oral drug developed by ARIAD Pharmaceuticals for the treatment of chronic myeloid leukemia (CML) and Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL). It is a multi-targeted tyrosine-kinase inhibitor.[2] Some forms of CML, those that have the T315I mutation, are resistant to current therapies such as imatinib. Ponatinib has been designed to be effective against these types of tumors.[3]
The United States Food and Drug Administration approved the drug as a candidate in December 2012, but temporarily suspended sales on 31 October 2013 because of "the risk of life-threatening blood clots and severe narrowing of blood vessels".[4][5] This suspension was partially lifted on Dec. 20, 2013 with ponatinib being issued revised prescribing information, a new "Black Box Warning" and a "Risk Evaluation and Mitigation Strategy" in place to better evaluate the risks and benefits of using the drug."
Extract of wikipedia
CLINICAL TRIALS
Ponatinib for CML Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL) (PACE)
Expanded Access Program of Ponatinib
A Study Comparing Ponatinib and Nilotinib in Patients With Chronic Myeloid Leukemia (OPTIC-2L)
Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias or Solid Tumors
Consolidation Treatment With Ponatinib 15 mg on Treatment Free-Remission Rate in Patients With Chronic Myeloid Leukemia
Ponatinib for CML Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL) (PACE)
Expanded Access Program of Ponatinib
A Study Comparing Ponatinib and Nilotinib in Patients With Chronic Myeloid Leukemia (OPTIC-2L)
Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias or Solid Tumors
Consolidation Treatment With Ponatinib 15 mg on Treatment Free-Remission Rate in Patients With Chronic Myeloid Leukemia
All clinical trials with ponatinib
VIDEOS
Chronic Myeloid Leukemia: Arterial Occlusive Events in the PACE Trial
October 28, 2022, Cancer Network
Efficacy and Toxicity Considerations for Use of Ponatinib
February 24, 2022, CancerNetwork
Optimal Ponatinib Dose Selection for a Given Patient Population
February 24, 2022, CancerNetwork
Clinical Implications of a Dose Ranging Study of Ponatinib for CML
February 17, 2022, CancerNetwork
Ponatinib Dose-Ranging Study in Chronic-Phase Chronic Myeloid Leukemia
February 17, 2022, CancerNetwork
VIDEO: Ponatinib dose-optimization beneficial for CML despite cardiac toxicity
July 7, 2021, Healio
VIDEO: High dose ponatinib benefits patients with chronic myeloid leukemia
June 22, 2021, Healio
Ponatinib in chronic-phase CML patients with prior second generation TKI exposure
December 7, 2020, VJHemOnc – Video Journal of Hematological Oncology
OPTIC: ponatinib in resistant chronic-phase CML
June 30, 2020, VJHemOnc – Video Journal of Hematological Oncology
Jorge E. Cortes, MD, on Chronic Phase CML: Comparing Three Starting Doses of Ponatinib
June 11-21, 2020, The ASCO Post
FLAG-IDA and ponatinib in blast phase CML: MATCHPOINT trial
January 24, 2020, VJHemOnc – Video Journal of Hematological Oncology
Dose-Related Adverse Events With Ponatinib When Treating CML
July 29, 2019, Targeted Oncology
Bosutinib Versus Ponatinib in R/R CML
July 22, 2019, Targeted Oncology
Early Intervention With Ponatinib in Treatment of CML
July 17, 2019, Targeted Oncology
Case 2: Ponatinib for T315I-Mutated CML
June 4, 2019, Targeted Oncology
Rationale for TKI Therapy in Relapsed CML
January 22, 2018, Targeted Oncology
Using ponatinib to treat highly resistant chronic myeloid leukemia, results from a Phase I trial
January 10, 2017, VJHemOnc
Modelling ponatinib resistance in BCR-ABL1 cell lines
August 3, 2016, ecancer
What are the efficacy and safety considerations in using ponatinib?
April 29, 2016, MediCom Oncology
Management of Thrombosis Risk with Ponatinib and other TKIs for CML?
May 15, 2015, ImedexCME
Epic:Phase 3 Trial of Ponatinib Compared with Imatinib in Newly Diagnosed Chronic Myeloid Leukemia
February 16, 2015, Oncology.TV
Treatment Selection for Resistant or Intolerant Chronic Myeloid Leukemia
February 24, 2014, OncLiveTV
More on Ponatinib and Next Steps - Harry Erba, MD
November 7, 2013, NationalCMLSociety
Considerations for Patients Taking Ponatinib - Michael Mauro, MD
November 5, 2013, NationalCMLSociety·
Dr. Jorge Cortes Discusses the Ponatinib Ph+All and CML Evaluation (PACE) Trial
June 14, 2012, OncLive
ARIAD: Xiaotian Zhu on Ponatinib
April 3, 2012, Executive video
Chronic Myeloid Leukemia: Arterial Occlusive Events in the PACE Trial
October 28, 2022, Cancer Network
Efficacy and Toxicity Considerations for Use of Ponatinib
February 24, 2022, CancerNetwork
Optimal Ponatinib Dose Selection for a Given Patient Population
February 24, 2022, CancerNetwork
Clinical Implications of a Dose Ranging Study of Ponatinib for CML
February 17, 2022, CancerNetwork
Ponatinib Dose-Ranging Study in Chronic-Phase Chronic Myeloid Leukemia
February 17, 2022, CancerNetwork
VIDEO: Ponatinib dose-optimization beneficial for CML despite cardiac toxicity
July 7, 2021, Healio
VIDEO: High dose ponatinib benefits patients with chronic myeloid leukemia
June 22, 2021, Healio
Ponatinib in chronic-phase CML patients with prior second generation TKI exposure
December 7, 2020, VJHemOnc – Video Journal of Hematological Oncology
OPTIC: ponatinib in resistant chronic-phase CML
June 30, 2020, VJHemOnc – Video Journal of Hematological Oncology
Jorge E. Cortes, MD, on Chronic Phase CML: Comparing Three Starting Doses of Ponatinib
June 11-21, 2020, The ASCO Post
FLAG-IDA and ponatinib in blast phase CML: MATCHPOINT trial
January 24, 2020, VJHemOnc – Video Journal of Hematological Oncology
Dose-Related Adverse Events With Ponatinib When Treating CML
July 29, 2019, Targeted Oncology
Bosutinib Versus Ponatinib in R/R CML
July 22, 2019, Targeted Oncology
Early Intervention With Ponatinib in Treatment of CML
July 17, 2019, Targeted Oncology
Case 2: Ponatinib for T315I-Mutated CML
June 4, 2019, Targeted Oncology
Rationale for TKI Therapy in Relapsed CML
January 22, 2018, Targeted Oncology
Using ponatinib to treat highly resistant chronic myeloid leukemia, results from a Phase I trial
January 10, 2017, VJHemOnc
Modelling ponatinib resistance in BCR-ABL1 cell lines
August 3, 2016, ecancer
What are the efficacy and safety considerations in using ponatinib?
April 29, 2016, MediCom Oncology
Management of Thrombosis Risk with Ponatinib and other TKIs for CML?
May 15, 2015, ImedexCME
Epic:Phase 3 Trial of Ponatinib Compared with Imatinib in Newly Diagnosed Chronic Myeloid Leukemia
February 16, 2015, Oncology.TV
Treatment Selection for Resistant or Intolerant Chronic Myeloid Leukemia
February 24, 2014, OncLiveTV
More on Ponatinib and Next Steps - Harry Erba, MD
November 7, 2013, NationalCMLSociety
Considerations for Patients Taking Ponatinib - Michael Mauro, MD
November 5, 2013, NationalCMLSociety·
Dr. Jorge Cortes Discusses the Ponatinib Ph+All and CML Evaluation (PACE) Trial
June 14, 2012, OncLive
ARIAD: Xiaotian Zhu on Ponatinib
April 3, 2012, Executive video
ARTICLES
Lower-Dose Ponatinib Appears Effective as Induction in Chronic Phase CML
December 11, 2023, Cancer Therapy Advisor
Ponatinib Dose-Ranging Data in Chronic-Phase CML
October 13, 2023, Cancer Network
Olverembatinib in Ponatinib-Resistant CML: Considerations for Later-Line Therapy
October 3, 2023, Cancer Therapy Advisor
Cross Q&A: Ponatinib Dosing in Relapsed/Refractory Chronic-Phase CML
July 28, 2023, Cancer Network
Ponatinib after TKI Failure in Chronic Myeloid Leukemia
November 4, 2022, Cancer Network
Optimal Biologic Dose of Ponatinib Reduces Adverse Events in CP-CML
October 12, 2022, Targeted Oncology
Real-Life Management of Chronic Myeloid Leukemia Patients Treated with Ponatinib
October 10, 2022, Physician Weekly
Ponatinib Yields Benefits Across 3 Dosage Regimens in Chronic-Phase Chronic Myeloid Leukemia
January 12, 2022, Hematology Advisor
Ponatinib, High-Dose Chemo Combo Likely to Benefit High-risk BP-CML
January 1, 2022, AJMC
STAT5 inhibitor Pimozide as a probable therapeutic option in overcoming Ponatinib resistance in K562 leukemic cells
November 28, 2021, PubMed
Dose-Optimization of Ponatinib in Patients With Resistant/Intolerant Chronic-Phase Chronic Myeloid Leukemia
September 10, 2021, Hematology Advisor
Registry Data Support Use of Ponatinib in CML, Ph+ ALL Resistant or Intolerant to Tyrosine Kinase Inhibitors
July 5, 2021, Oncology Nurse Advisor
Response-Based Ponatinib Dosing Appears Effective in Chronic Phase Chronic Myeloid Leukemia
June 5, 2021, Cancer Therapy Advisor
Dr Christopher Arendt on OPTIC Findings for Dose Optimization of Ponatinib in Patients With CP-CML
June 5, 2021, AJMC
Takeda to Present Positive Primary Analysis from Phase 2 OPTIC Trial of ICLUSIG® (ponatinib), Reinforcing Ability to Address Gaps in Care for Chronic-Phase CML
May 19, 2021, Takeda
Dr. Cortes Discusses Approval of Ponatinib for Adults with Chronic-phase CML
February 5, 2021, docwirenews
FDA Approves Ponatinib To Treat Adult Patients with Resistant/Intolerant Chronic-Phase CML
December 18, 2020, Cancer Network
U.S. FDA Approves Supplemental New Drug Application for Takeda’s ICLUSIG® (ponatinib) for Adult Patients with Resistant or Intolerant Chronic-Phase CML
2020-12-18, Takeda
Ponatinib Demonstrates Efficacy Over Time for Patients With CP-CML After Prior TKI Failure
December 7, 2020, Targeted Oncology
Efficacy and Safety of Ponatinib (PON) in Patients with Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Who Failed One or More Second-Generation (2G) Tyrosine Kinase Inhibitors (TKIs): Analyses Based on PACE and Optic
December 7, 2020, ASH 2020
Outcome By Mutation Status and Line of Treatment in Optic, a Dose-Ranging Study of 3 Starting Doses of Ponatinib in Patients with CP-CML
December 7, 2020, ASH 2020
Evaluation of the plasma concentration of ponatinib in a chronic myeloid leukaemia patient with ponatinib intolerance
September 28, 2020, PubMed
Ponatinib starting dose may be linked to efficacy, safety in chronic-phase CML
September 15, 2020, Healio
Ponatinib and Other CML Tyrosine Kinase Inhibitors in Thrombosis
September 8, 2020, International Journal of Molecular Sciences
Takeda to Present Data from the ICLUSIG® (ponatinib) Clinical Trial Program that Could Prove Practice-Changing for the Treatment of Chronic-Phase CML
May 29, 2020, Takeda
Side-effects profile and outcomes of ponatinib in the treatment of chronic myeloid leukemia
February 11, 2020, Blood Advance
Ponatinib in the Treatment of Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Leukemia: Recommendations of a German Expert Consensus Panel with Focus on Cardiovascular Management
October 7, 2019, PubMed
Combining the Allosteric Inhibitor Asciminib with Ponatinib Suppresses Emergence of and Restores Efficacy against Highly Resistant BCR-ABL1 Mutants
September 4, 2019, PubMed
Rechallenge of ponatinib in chronic myeloid leukaemia after hepatotoxicity
April 2019, Hong Kong Medical Journal
Pre- and post-transplant ponatinib for a patient with acute megakaryoblastic blast phase chronic myeloid leukemia with T315I mutation who underwent allogeneic hematopoietic stem cell transplantation
March 16, 2019, PubMed
Arterial Occlusive Events in Chronic Myeloid Leukemia Patients Treated with Ponatinib in the Real-Life Practice: Prophylaxis and Identification of Risk Factors
November 29, 2018, Blood
Ponatinib Tops Bosutinib for Third-Line Treatment of CML in a Comparative Analysis
October 15, 2018, Cancer Therapy Advisor
Real-life Experience With Ponatinib in Chronic Myeloid Leukemia: A Multicenter Observational Study
May 7, 2018, PubMed
Analyst 'would not be surprised' to see Takeda retry Iclusig in first-line CML
March 25, 2018, The Pharma Letter
Takeda Announces Publication of Final Data from ICLUSIG® (ponatinib) Pivotal Phase 2 PACE Trial in Blood
March 22, 2018, Boston Business Journal
Publication of Final Data from ICLUSIG (ponatinib) Pivotal Phase 2 PACE Trial
March 22, 2018, Drug Discovery & Development
Ponatinib Maintains Benefit in Chronic-Phase CML at 5 Years
March 22, 2018, OncLive
Ponatinib Shows Promise for Rare Ovarian Cancer Type that Affects Young Women
March 8, 2018, Oncology Nursing News
Efficacy and Safety of Ponatinib in Chronic Phase-Chronic Myeloid Leukemia (CP-CML) According to the Extent of Treatment with Prior Tyrosine Kinase Inhibitors (TKIs): Final (5-Year) Results of the PACE Study
December 2017, ASH 2017
A Conservative Tailoring of Ponatinib Dose in Chronic Myeloid Leukemia Patients Can Diminish Adverse Events While Maintaining Efficacy
December 2017, ASH 2017
Arterial Occlusive Events (AOEs) in the Phase 2 Ponatinib PACE Trial: 5-Year Update in Heavily Treated Patients (Pts) with Chronic-Phase Chronic Myeloid Leukemia (CP-CML)
December 2017, ASH 2017
A Real Life Evaluation of Efficacy and Safety of Ponatinib Therapy in CML Patients
December 2017, ASH 2017
Life after ponatinib failure: outcomes of chronic and accelerated phase CML patients who discontinued ponatinib in the salvage setting
October 2017, PublMed
Ponatinib: Black Box Warning and Drug Interactions
January 17, 2017, Cancer Therapy Advisor
The impact of multiple low-level BCR-ABL1 mutations on response to ponatinib
April 14, 2016, NCBI
Ponatinib and Cardiovascular Complications
December 4, 2016, ASH 2016
Ponatinib in Chronic-Phase Chronic Myeloid Leukemia Patients: Final Report from a Phase 1 Trial
December 4, 2016, ASH 2016
Long-Term Follow-up of the Efficacy and Safety of Ponatinib in Philadelphia Chromosome-Positive Leukemia Patients with the T315I Mutation
December 4, 2016, ASH 2016
Imatinib as Second-Line Therapy, Ameliorates or Maintains Molecular Responses Obtained with Ponatinib First-Line in Chronic Phase CML Patients
December 3, 2016, ASH 2016
Ponatinib Approved for CP-CML Not Indicated for Prior TKI
December 1, 2016, Cancer Therapy Advisor
Response Rate Similar Between Low- and Standard-dose Ponatinib
September 23, 2016, Cancer Therapy Advisor
Efficacy and safety of second-line ponatinib after failure of a single previous tyrosine kinase inhibitor for chronic myeloid leukemia patients in chronic phase
June 2016, Haematologica
ARIAD Announces Long-Term Safety and Efficacy Data of Ponatinib from Phase 2 Pace Clinical Trial
June 13, 2016, Business Wire
Vascular Events Remain Problem for Ponatinib in CML
Apr 22, 2016, Cancer Network
The impact of multiple low-level BCR-ABL1 mutations on response to ponatinib
April 14, 2016, NCBI
Ponatinib versus imatinib for newly diagnosed chronic myeloid leukaemia: an international, randomised, open-label, phase 3 trial
April 12, 2016, NCBI
Ponatinib vs Allogeneic SCT Promising for T315I Mutation-positive CP-CML
January 11, 2016, Cancertherapyadvisor
Four-year minimum follow-up of ongoing patients (pts) with chronic-phase chronic myeloid leukemia (CP-CML) in a phase 1 trial of ponatinib (PON)
June 2015, 2015 ASCO Annual Meeting
Elevated blood pressure (BP) and adverse events (AEs) of hypertension (HTN) in ponatinib (PON) leukemia trials.
June 2015, 2015 ASCO Annual Meeting
Efficacy and safety of ponatinib in heavily pretreated leukemia patients in the PACE trial: 3-year results.
June 2015, 2015 ASCO Annual Meeting
Long-term Bosutinib in patients with chronic phase CML after prior imatinib failure
June 2015, EHA 2015
Ponatinib efficacy and safety in heavily pretreated leukemia patients: 3-year results of the Pace trial
June 2015, EHA 2015
Ponatinib efficacy and safety in heavily pretreated leukemia patients: 3-year results of the Pace trial
June 2015, EHA 2015
Long-term follow-up of ponatinib effivacy and safety in patients (PTS) with the T315I mutation in the phase 1 and phase 2(pace) trials.
June 2015, EHA 2015
Elavated Blood Pressure ans adverse events of hypertension in phase 1,2 and 3 trials of ponationib in leukemia
June 2015, EHA 2015
T315I clone selectioin in a PH+ All patient under maintenance Ponatinib
June 2015, EHA 2015
Hematologic safety data of single-agent ponatinib from a phase I and phase II trial in Philadelphia chromosome-positive (Ph+) CML/ALL patients
June 2, 2014, 2014 ASCO Annual Meeting
Longer-term follow up of a phase 1 study of ponatinib in patients (pts) with Philadelphia chromosome-positive (Ph+) leukemias
June 2, 2014, 2014 ASCO Annual Meeting
EPIC: A phase III trial of ponatinib (PON) versus imatinib (IM) in patients (pts) with newly diagnosed CP-CML
May 31, 2014, 2014 ASCO Annual Meeting
ARIAD Announces Commercial Agreement for Iclusig (Ponatinib) in Australia
January 28, 2014, Business Wire
Patients' advocates press FDA to retain lifesaving drugs (Iclusig)
November 24, 2013, Boston Globe
Ariad jumps on European drug action
November 23, 2013, Boston Globe
European Medicines Agency recommends changes in use of leukaemia medicine Iclusig (ponatinib) in order to minimise
risk of blood clots
November 22, 2013, European Medicine Agency
Ponatinib demonstrated activity in patients with CML, Ph+ALL
November 21, 2013, HemOnctoday
PRAC updates on the risks of serious vascular occlusive events associated with cancer medicine Iclusig
November 8, 2013, European Medicines Agency
Doctors Fear Losing Leukemia Drug Deemed Risky
November 1, 2013, New York Times
The Leukemia & Lymphoma Society Issues Statement Regarding the Status of Iclusig
November 1, 2013, DigitalJournal.com
Serious Danger of Blood Clots Halts Sale of Leukemia Drug
October 31, 2013, New York Times
Genetic details of leukemia resistance
October 31, 2013, Oncology Nurse Advisor
Ariad announces discontinuation of a trial for its leukemia drug
October 18, 2013, boston.com
Ariad crushed (again) after PhIII Iclusig trial is shuttered on blood clot fears
October 18, 2013, FierceBiotech
Ariad Stops Phase 3 Epic Trial Of Iclusig In Patients With Newly Diagnosed CML
October 18, 2013, RTT News
Safety Concerns Halt Ponatinib Development
October 9, 2013, Onc LIve
Ponatinib—A Step Forward in Overcoming Resistance in Chronic Myeloid Leukemia
August 5, 2013, Clinical cancer Research
Effects of food on the pharmacokinetics of ponatinib in healthy subjects.
July 25, 2013, PublMed
New TKI Ponatinib Effective in Resistant CML
February 2013, Clinical Oncology News
Ponatinib Could Herald “Revolution”in CML Treatment
December 20, 2012, OncLive
Ponatinib in Refractory Philadelphia Chromosome–Positive Leukemias
November 29, 2012, The New England Journal of Medicine
F.D.A. Gives Early Approval to Drug for Rare Leukemia
December 14, 2012, The New York Times
OHSU-developed ponatinib wins FDA approval
December 14, 2012, Portland Business Journal
FDA grants approval for potential ‘blockbuster’ leukemia drug made by Cambridge-based Ariad
December 14, 2012, Boston.com
ARIAD Announces Accelerated Approval by FDA of Iclusig (Ponatinib) for Patients with CML and Ph+ ALL Resistant or Intolerant to Prior Tyrosine Kinase Inhibitor Therapy
December 14, 2012, Fierce Biotech
FDA Approves Ariad Pharma Leukemia Drug
December 14, 2012, The Street
Ponatinib offers new hope in drug-resistant leukemia
December 5, 2012 , News-Medical.net
Chronic Myeloid Leukemia Mutation Thwarted By Ponatinib
December 2, 2012, Science 2.0
Data Published on ARIAD Candidate - Analyst Blog
November 30, 2012, Nasdaq
In CML, Next-Generation TKIs Aim to Boost Outcomes
November 30, 2012, Onc LIve
Ponatinib thwarts T315I gene mutation in chronic myeloid leukemia
November 29, 2012, News Medical
Ponatinib for Chronic Myeloid Leukemia
November 29, 2012, The New England Journal of Medicine
Ponatinib acts against the most resistant types of chronic myeloid leukemia
November 28, 2012, Science Codex
Ponatinib Acts Against the Most Resistant Types of Chronic Myeloid Leukemia
November 28, 2012, Science Daily
FDA Agrees to Speed Review of Ariad Drug
October 25, 2012, DailyFinance
Ariad Pharmaceuticals: Ponatinib Approval Anticipated In Second-Line CML
October 1, 2012, Seeking Alpha
ARIAD Announces Submission of Marketing Authorization Application for Ponatinib to the European Medicines Agency
August. 30, 2012, Fierce Pharma.
Ariad Pharmaceuticals Gearing Up For Ponatinib's Approval
August 29, 2012, Seeking Alpha
ARIAD Pharma initiates phase I/II trial of ponatinib in Japan
August 22, 2012, Pharmabiz.com
Accelerated FDA Approval for CML Drug Ponatinib Sought
August 9, 2012, Cancer Network
Ponatinib Achieves Primary Endpoints in CML Subtypes
August 8, 2012, OncLive
Ariad Prepares for Early Launch of CML Drug Ponatinib
August 6, 2012, Oncology Stat
Ariad speeds targeted leukemia drug to FDA in race for key approval
July 31, 2012, FierceBiotech
Ariad Pharma ANNOUNCES Phase 3 Trial and 4 Stocks Hitting 52-Week Highs
July 28, 2012, Wall St . Cheqt Sheet
Platelet dysfunction associated with ponatinib, a new pan BCR-ABL inhibitor with efficacy for chronic myeloid leukemia resistant to multiple tyrosine kinase inhibitor therapy
April 24, 2012, Haematologica
Lower-Dose Ponatinib Appears Effective as Induction in Chronic Phase CML
December 11, 2023, Cancer Therapy Advisor
Ponatinib Dose-Ranging Data in Chronic-Phase CML
October 13, 2023, Cancer Network
Olverembatinib in Ponatinib-Resistant CML: Considerations for Later-Line Therapy
October 3, 2023, Cancer Therapy Advisor
Cross Q&A: Ponatinib Dosing in Relapsed/Refractory Chronic-Phase CML
July 28, 2023, Cancer Network
Ponatinib after TKI Failure in Chronic Myeloid Leukemia
November 4, 2022, Cancer Network
Optimal Biologic Dose of Ponatinib Reduces Adverse Events in CP-CML
October 12, 2022, Targeted Oncology
Real-Life Management of Chronic Myeloid Leukemia Patients Treated with Ponatinib
October 10, 2022, Physician Weekly
Ponatinib Yields Benefits Across 3 Dosage Regimens in Chronic-Phase Chronic Myeloid Leukemia
January 12, 2022, Hematology Advisor
Ponatinib, High-Dose Chemo Combo Likely to Benefit High-risk BP-CML
January 1, 2022, AJMC
STAT5 inhibitor Pimozide as a probable therapeutic option in overcoming Ponatinib resistance in K562 leukemic cells
November 28, 2021, PubMed
Dose-Optimization of Ponatinib in Patients With Resistant/Intolerant Chronic-Phase Chronic Myeloid Leukemia
September 10, 2021, Hematology Advisor
Registry Data Support Use of Ponatinib in CML, Ph+ ALL Resistant or Intolerant to Tyrosine Kinase Inhibitors
July 5, 2021, Oncology Nurse Advisor
Response-Based Ponatinib Dosing Appears Effective in Chronic Phase Chronic Myeloid Leukemia
June 5, 2021, Cancer Therapy Advisor
Dr Christopher Arendt on OPTIC Findings for Dose Optimization of Ponatinib in Patients With CP-CML
June 5, 2021, AJMC
Takeda to Present Positive Primary Analysis from Phase 2 OPTIC Trial of ICLUSIG® (ponatinib), Reinforcing Ability to Address Gaps in Care for Chronic-Phase CML
May 19, 2021, Takeda
Dr. Cortes Discusses Approval of Ponatinib for Adults with Chronic-phase CML
February 5, 2021, docwirenews
FDA Approves Ponatinib To Treat Adult Patients with Resistant/Intolerant Chronic-Phase CML
December 18, 2020, Cancer Network
U.S. FDA Approves Supplemental New Drug Application for Takeda’s ICLUSIG® (ponatinib) for Adult Patients with Resistant or Intolerant Chronic-Phase CML
2020-12-18, Takeda
Ponatinib Demonstrates Efficacy Over Time for Patients With CP-CML After Prior TKI Failure
December 7, 2020, Targeted Oncology
Efficacy and Safety of Ponatinib (PON) in Patients with Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Who Failed One or More Second-Generation (2G) Tyrosine Kinase Inhibitors (TKIs): Analyses Based on PACE and Optic
December 7, 2020, ASH 2020
Outcome By Mutation Status and Line of Treatment in Optic, a Dose-Ranging Study of 3 Starting Doses of Ponatinib in Patients with CP-CML
December 7, 2020, ASH 2020
Evaluation of the plasma concentration of ponatinib in a chronic myeloid leukaemia patient with ponatinib intolerance
September 28, 2020, PubMed
Ponatinib starting dose may be linked to efficacy, safety in chronic-phase CML
September 15, 2020, Healio
Ponatinib and Other CML Tyrosine Kinase Inhibitors in Thrombosis
September 8, 2020, International Journal of Molecular Sciences
Takeda to Present Data from the ICLUSIG® (ponatinib) Clinical Trial Program that Could Prove Practice-Changing for the Treatment of Chronic-Phase CML
May 29, 2020, Takeda
Side-effects profile and outcomes of ponatinib in the treatment of chronic myeloid leukemia
February 11, 2020, Blood Advance
Ponatinib in the Treatment of Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Leukemia: Recommendations of a German Expert Consensus Panel with Focus on Cardiovascular Management
October 7, 2019, PubMed
Combining the Allosteric Inhibitor Asciminib with Ponatinib Suppresses Emergence of and Restores Efficacy against Highly Resistant BCR-ABL1 Mutants
September 4, 2019, PubMed
Rechallenge of ponatinib in chronic myeloid leukaemia after hepatotoxicity
April 2019, Hong Kong Medical Journal
Pre- and post-transplant ponatinib for a patient with acute megakaryoblastic blast phase chronic myeloid leukemia with T315I mutation who underwent allogeneic hematopoietic stem cell transplantation
March 16, 2019, PubMed
Arterial Occlusive Events in Chronic Myeloid Leukemia Patients Treated with Ponatinib in the Real-Life Practice: Prophylaxis and Identification of Risk Factors
November 29, 2018, Blood
Ponatinib Tops Bosutinib for Third-Line Treatment of CML in a Comparative Analysis
October 15, 2018, Cancer Therapy Advisor
Real-life Experience With Ponatinib in Chronic Myeloid Leukemia: A Multicenter Observational Study
May 7, 2018, PubMed
Analyst 'would not be surprised' to see Takeda retry Iclusig in first-line CML
March 25, 2018, The Pharma Letter
Takeda Announces Publication of Final Data from ICLUSIG® (ponatinib) Pivotal Phase 2 PACE Trial in Blood
March 22, 2018, Boston Business Journal
Publication of Final Data from ICLUSIG (ponatinib) Pivotal Phase 2 PACE Trial
March 22, 2018, Drug Discovery & Development
Ponatinib Maintains Benefit in Chronic-Phase CML at 5 Years
March 22, 2018, OncLive
Ponatinib Shows Promise for Rare Ovarian Cancer Type that Affects Young Women
March 8, 2018, Oncology Nursing News
Efficacy and Safety of Ponatinib in Chronic Phase-Chronic Myeloid Leukemia (CP-CML) According to the Extent of Treatment with Prior Tyrosine Kinase Inhibitors (TKIs): Final (5-Year) Results of the PACE Study
December 2017, ASH 2017
A Conservative Tailoring of Ponatinib Dose in Chronic Myeloid Leukemia Patients Can Diminish Adverse Events While Maintaining Efficacy
December 2017, ASH 2017
Arterial Occlusive Events (AOEs) in the Phase 2 Ponatinib PACE Trial: 5-Year Update in Heavily Treated Patients (Pts) with Chronic-Phase Chronic Myeloid Leukemia (CP-CML)
December 2017, ASH 2017
A Real Life Evaluation of Efficacy and Safety of Ponatinib Therapy in CML Patients
December 2017, ASH 2017
Life after ponatinib failure: outcomes of chronic and accelerated phase CML patients who discontinued ponatinib in the salvage setting
October 2017, PublMed
Ponatinib: Black Box Warning and Drug Interactions
January 17, 2017, Cancer Therapy Advisor
The impact of multiple low-level BCR-ABL1 mutations on response to ponatinib
April 14, 2016, NCBI
Ponatinib and Cardiovascular Complications
December 4, 2016, ASH 2016
Ponatinib in Chronic-Phase Chronic Myeloid Leukemia Patients: Final Report from a Phase 1 Trial
December 4, 2016, ASH 2016
Long-Term Follow-up of the Efficacy and Safety of Ponatinib in Philadelphia Chromosome-Positive Leukemia Patients with the T315I Mutation
December 4, 2016, ASH 2016
Imatinib as Second-Line Therapy, Ameliorates or Maintains Molecular Responses Obtained with Ponatinib First-Line in Chronic Phase CML Patients
December 3, 2016, ASH 2016
Ponatinib Approved for CP-CML Not Indicated for Prior TKI
December 1, 2016, Cancer Therapy Advisor
Response Rate Similar Between Low- and Standard-dose Ponatinib
September 23, 2016, Cancer Therapy Advisor
Efficacy and safety of second-line ponatinib after failure of a single previous tyrosine kinase inhibitor for chronic myeloid leukemia patients in chronic phase
June 2016, Haematologica
ARIAD Announces Long-Term Safety and Efficacy Data of Ponatinib from Phase 2 Pace Clinical Trial
June 13, 2016, Business Wire
Vascular Events Remain Problem for Ponatinib in CML
Apr 22, 2016, Cancer Network
The impact of multiple low-level BCR-ABL1 mutations on response to ponatinib
April 14, 2016, NCBI
Ponatinib versus imatinib for newly diagnosed chronic myeloid leukaemia: an international, randomised, open-label, phase 3 trial
April 12, 2016, NCBI
Ponatinib vs Allogeneic SCT Promising for T315I Mutation-positive CP-CML
January 11, 2016, Cancertherapyadvisor
Four-year minimum follow-up of ongoing patients (pts) with chronic-phase chronic myeloid leukemia (CP-CML) in a phase 1 trial of ponatinib (PON)
June 2015, 2015 ASCO Annual Meeting
Elevated blood pressure (BP) and adverse events (AEs) of hypertension (HTN) in ponatinib (PON) leukemia trials.
June 2015, 2015 ASCO Annual Meeting
Efficacy and safety of ponatinib in heavily pretreated leukemia patients in the PACE trial: 3-year results.
June 2015, 2015 ASCO Annual Meeting
Long-term Bosutinib in patients with chronic phase CML after prior imatinib failure
June 2015, EHA 2015
Ponatinib efficacy and safety in heavily pretreated leukemia patients: 3-year results of the Pace trial
June 2015, EHA 2015
Ponatinib efficacy and safety in heavily pretreated leukemia patients: 3-year results of the Pace trial
June 2015, EHA 2015
Long-term follow-up of ponatinib effivacy and safety in patients (PTS) with the T315I mutation in the phase 1 and phase 2(pace) trials.
June 2015, EHA 2015
Elavated Blood Pressure ans adverse events of hypertension in phase 1,2 and 3 trials of ponationib in leukemia
June 2015, EHA 2015
T315I clone selectioin in a PH+ All patient under maintenance Ponatinib
June 2015, EHA 2015
Hematologic safety data of single-agent ponatinib from a phase I and phase II trial in Philadelphia chromosome-positive (Ph+) CML/ALL patients
June 2, 2014, 2014 ASCO Annual Meeting
Longer-term follow up of a phase 1 study of ponatinib in patients (pts) with Philadelphia chromosome-positive (Ph+) leukemias
June 2, 2014, 2014 ASCO Annual Meeting
EPIC: A phase III trial of ponatinib (PON) versus imatinib (IM) in patients (pts) with newly diagnosed CP-CML
May 31, 2014, 2014 ASCO Annual Meeting
ARIAD Announces Commercial Agreement for Iclusig (Ponatinib) in Australia
January 28, 2014, Business Wire
Patients' advocates press FDA to retain lifesaving drugs (Iclusig)
November 24, 2013, Boston Globe
Ariad jumps on European drug action
November 23, 2013, Boston Globe
European Medicines Agency recommends changes in use of leukaemia medicine Iclusig (ponatinib) in order to minimise
risk of blood clots
November 22, 2013, European Medicine Agency
Ponatinib demonstrated activity in patients with CML, Ph+ALL
November 21, 2013, HemOnctoday
PRAC updates on the risks of serious vascular occlusive events associated with cancer medicine Iclusig
November 8, 2013, European Medicines Agency
Doctors Fear Losing Leukemia Drug Deemed Risky
November 1, 2013, New York Times
The Leukemia & Lymphoma Society Issues Statement Regarding the Status of Iclusig
November 1, 2013, DigitalJournal.com
Serious Danger of Blood Clots Halts Sale of Leukemia Drug
October 31, 2013, New York Times
Genetic details of leukemia resistance
October 31, 2013, Oncology Nurse Advisor
Ariad announces discontinuation of a trial for its leukemia drug
October 18, 2013, boston.com
Ariad crushed (again) after PhIII Iclusig trial is shuttered on blood clot fears
October 18, 2013, FierceBiotech
Ariad Stops Phase 3 Epic Trial Of Iclusig In Patients With Newly Diagnosed CML
October 18, 2013, RTT News
Safety Concerns Halt Ponatinib Development
October 9, 2013, Onc LIve
Ponatinib—A Step Forward in Overcoming Resistance in Chronic Myeloid Leukemia
August 5, 2013, Clinical cancer Research
Effects of food on the pharmacokinetics of ponatinib in healthy subjects.
July 25, 2013, PublMed
New TKI Ponatinib Effective in Resistant CML
February 2013, Clinical Oncology News
Ponatinib Could Herald “Revolution”in CML Treatment
December 20, 2012, OncLive
Ponatinib in Refractory Philadelphia Chromosome–Positive Leukemias
November 29, 2012, The New England Journal of Medicine
F.D.A. Gives Early Approval to Drug for Rare Leukemia
December 14, 2012, The New York Times
OHSU-developed ponatinib wins FDA approval
December 14, 2012, Portland Business Journal
FDA grants approval for potential ‘blockbuster’ leukemia drug made by Cambridge-based Ariad
December 14, 2012, Boston.com
ARIAD Announces Accelerated Approval by FDA of Iclusig (Ponatinib) for Patients with CML and Ph+ ALL Resistant or Intolerant to Prior Tyrosine Kinase Inhibitor Therapy
December 14, 2012, Fierce Biotech
FDA Approves Ariad Pharma Leukemia Drug
December 14, 2012, The Street
Ponatinib offers new hope in drug-resistant leukemia
December 5, 2012 , News-Medical.net
Chronic Myeloid Leukemia Mutation Thwarted By Ponatinib
December 2, 2012, Science 2.0
Data Published on ARIAD Candidate - Analyst Blog
November 30, 2012, Nasdaq
In CML, Next-Generation TKIs Aim to Boost Outcomes
November 30, 2012, Onc LIve
Ponatinib thwarts T315I gene mutation in chronic myeloid leukemia
November 29, 2012, News Medical
Ponatinib for Chronic Myeloid Leukemia
November 29, 2012, The New England Journal of Medicine
Ponatinib acts against the most resistant types of chronic myeloid leukemia
November 28, 2012, Science Codex
Ponatinib Acts Against the Most Resistant Types of Chronic Myeloid Leukemia
November 28, 2012, Science Daily
FDA Agrees to Speed Review of Ariad Drug
October 25, 2012, DailyFinance
Ariad Pharmaceuticals: Ponatinib Approval Anticipated In Second-Line CML
October 1, 2012, Seeking Alpha
ARIAD Announces Submission of Marketing Authorization Application for Ponatinib to the European Medicines Agency
August. 30, 2012, Fierce Pharma.
Ariad Pharmaceuticals Gearing Up For Ponatinib's Approval
August 29, 2012, Seeking Alpha
ARIAD Pharma initiates phase I/II trial of ponatinib in Japan
August 22, 2012, Pharmabiz.com
Accelerated FDA Approval for CML Drug Ponatinib Sought
August 9, 2012, Cancer Network
Ponatinib Achieves Primary Endpoints in CML Subtypes
August 8, 2012, OncLive
Ariad Prepares for Early Launch of CML Drug Ponatinib
August 6, 2012, Oncology Stat
Ariad speeds targeted leukemia drug to FDA in race for key approval
July 31, 2012, FierceBiotech
Ariad Pharma ANNOUNCES Phase 3 Trial and 4 Stocks Hitting 52-Week Highs
July 28, 2012, Wall St . Cheqt Sheet
Platelet dysfunction associated with ponatinib, a new pan BCR-ABL inhibitor with efficacy for chronic myeloid leukemia resistant to multiple tyrosine kinase inhibitor therapy
April 24, 2012, Haematologica
Ponatinib Continues to Impress in Patients with Leukemia
February 15, 2012, The ASCO Post
Ariad Pharmaceuticals Still Might Have Upside
December 21, 2011, Investor Place
Ariad's ponatinib takes center stage with promising pivotal leukemia data
December 12, 2011, Fierce Biotech
Drug For Chronic Myeloid Leukemia To Be Out Soon
December 12, 2011, TopNews
Initial Findings from the PACE trial: A Pivotal Phase 2 Study of Ponatinib in Patients with CML and Ph+All
Resistant or Intolerant or Dasatinib or Nilotinib, or with the T315I Mutation
December 2, 2011, ASH Publications
Ariad Pharma: Early Efficacy, Safety of Leukemia Drug 'Striking'
November 7, 2011, The Street
ARIAD Presents New Preclinical Data On Ponatinib In Solid Tumors, Demonstrating Inhibition Of All FGF Receptor Kinases
April 6, 2011, Business Wire
Phase I Trial Shows Ponatinib May Thwart Most Resistant CML
December 16, 2010, MD Anderson Cancer Center - Department of Leukemia
Updated Phase 1 study data of ponatinib in patients with refractory CML, Ph+ ALL presented at ASH
December 6, 2010 , News medical
Novel CML Drug Active After Failures of Imatinib, Dasatinib, and Nilotinib
December 6, 2010, Oncology Stat
ARIAD Announces Initiation Of Ponatinib (AP24534) Pivotal Trial In Drug-Resistant Or Intolerant Chronic Myeloid Leukemia
September 2010, Fierce Biotech
Phase 2 trial of ponatinib for the treatment of chronic myeloid leukemia (CML) and Philadelphia positive acute lymphoblastic leukemia (Ph+ ALL)
September 2010, MPR
February 15, 2012, The ASCO Post
Ariad Pharmaceuticals Still Might Have Upside
December 21, 2011, Investor Place
Ariad's ponatinib takes center stage with promising pivotal leukemia data
December 12, 2011, Fierce Biotech
Drug For Chronic Myeloid Leukemia To Be Out Soon
December 12, 2011, TopNews
Initial Findings from the PACE trial: A Pivotal Phase 2 Study of Ponatinib in Patients with CML and Ph+All
Resistant or Intolerant or Dasatinib or Nilotinib, or with the T315I Mutation
December 2, 2011, ASH Publications
Ariad Pharma: Early Efficacy, Safety of Leukemia Drug 'Striking'
November 7, 2011, The Street
ARIAD Presents New Preclinical Data On Ponatinib In Solid Tumors, Demonstrating Inhibition Of All FGF Receptor Kinases
April 6, 2011, Business Wire
Phase I Trial Shows Ponatinib May Thwart Most Resistant CML
December 16, 2010, MD Anderson Cancer Center - Department of Leukemia
Updated Phase 1 study data of ponatinib in patients with refractory CML, Ph+ ALL presented at ASH
December 6, 2010 , News medical
Novel CML Drug Active After Failures of Imatinib, Dasatinib, and Nilotinib
December 6, 2010, Oncology Stat
ARIAD Announces Initiation Of Ponatinib (AP24534) Pivotal Trial In Drug-Resistant Or Intolerant Chronic Myeloid Leukemia
September 2010, Fierce Biotech
Phase 2 trial of ponatinib for the treatment of chronic myeloid leukemia (CML) and Philadelphia positive acute lymphoblastic leukemia (Ph+ ALL)
September 2010, MPR
See also Mutation T315I
