Ponatinib: A review of its use in adults with chronic myeloid leukaemia or philadelphia chromosome-positive acute lymphoblastic leukaemia

Drugs

Volumn 74, Issue 7, 2014, Pages 793-806

  Hoy, Sheridan M ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ABELSON KINASE; ALANINE AMINOTRANSFERASE; AMYLASE; ANGIOPOIETIN RECEPTOR; ASPARTATE AMINOTRANSFERASE; BREAST CANCER RESISTANCE PROTEIN; CLARITHROMYCIN; CRK LIKE PROTEIN; CYTOCHROME P450 1A2; CYTOCHROME P450 2B6; CYTOCHROME P450 2C19; CYTOCHROME P450 2C8; CYTOCHROME P450 2C9; CYTOCHROME P450 2D6; CYTOCHROME P450 3A; CYTOCHROME P450 3A4; CYTOCHROME P450 3A5; DASATINIB; EPHRIN RECEPTOR; FIBROBLAST GROWTH FACTOR RECEPTOR; FLT3 LIGAND; KETOCONAZOLE; MULTIDRUG RESISTANCE PROTEIN; NEFAZODONE; NILOTINIB; PONATINIB; PROTEIN RET; RITONAVIR; TRIACYLGLYCEROL LIPASE; VASCULOTROPIN RECEPTOR; ANTINEOPLASTIC AGENT; BCR ABL PROTEIN; IMIDAZOLE DERIVATIVE; PROTEIN KINASE INHIBITOR; PYRIDAZINE DERIVATIVE;

ABDOMINAL PAIN; ACUTE HEART INFARCTION; ACUTE LYMPHOBLASTIC LEUKEMIA; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AMYLASE BLOOD LEVEL; ANEMIA; AREA UNDER THE CURVE; ARTERY OCCLUSION; ARTHRALGIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BLOOD VESSEL OCCLUSION; BONE MARROW SUPPRESSION; BRAIN INFARCTION; CANCER SURVIVAL; CARDIOVASCULAR RISK; CHRONIC MYELOID LEUKEMIA; CONSTIPATION; CREATININE CLEARANCE; CYTOGENETICS; DEEP VEIN THROMBOSIS; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG METABOLISM; DRUG SOLUBILITY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DRY SKIN; FATIGUE; FOLLOW UP; GASTROINTESTINAL HEMORRHAGE; GENE MUTATION; GRAPEFRUIT JUICE; HEART ARREST; HEART FAILURE; HUMAN; HYPERTENSION; HYPERTENSIVE CRISIS; IC 50; LIVER TOXICITY; LONG TERM CARE; LUNG EMBOLISM; LUNG MYCOSIS; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MULTICENTER STUDY (TOPIC); MYELODYSPLASTIC SYNDROME; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PANCREATITIS; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHILADELPHIA CHROMOSOME POSITIVE CELL; PNEUMONIA; PROGRESSION FREE SURVIVAL; RECOMMENDED DRUG DOSE; SEPSIS; SIDE EFFECT; STEADY STATE; THROMBOCYTOPENIA; THROMBOSIS; TREATMENT RESPONSE; TRIACYLGLYCEROL LIPASE BLOOD LEVEL; VENOUS THROMBOEMBOLISM; ADULT; ANTAGONISTS AND INHIBITORS; CHEMISTRY; ENZYMOLOGY; GENETICS; LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE; METABOLISM; PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA;

ADULT; ANTINEOPLASTIC AGENTS; FUSION PROTEINS, BCR-ABL; HUMANS; IMIDAZOLES; LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE; PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA; PROTEIN KINASE INHIBITORS; PYRIDAZINES;

EID: 84901839773     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-014-0216-6     Document Type: Article

References (27)

1. Cortes J, Goldman JM, Hughes T. Current issues in chronic myeloid leukemia: monitoring, resistance, and functional cure. J Natl Compr Cancer Netw. 2012;10(Suppl 3):S1-13.
2. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: chronic myelogenous leukemia (version 3.2014). 2014. http://www.nccn.org/professionals/physician-gls/pdf/cml.pdf. Accessed 11 April 2014.
3. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: acute lymphoblastic leukemia (version 3.2013). 2013. http://www.nccn.org/professionals/physician-gls/pdf/all.pdf. Accessed 11 April 2014.
4. O'Hare T, Deininger MWN, Eide CA, et al. Targeting the BCR-ABL signaling pathway in therapy-resistant Philadelphia chromosome-positive leukemia. Clin Cancer Res. 2011;17(2):212-21.
5. Baccarani M, Deininger MW, Rosti G, et al. European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood. 2013;122(6):872-84.
6. Khorashad JS, de Lavallade H, Apperley JF, et al. Finding of kinase domain mutations in patients with chronic phase chronic myeloid leukemia responding to imatinib may identify those at high risk of disease progression. J Clin Oncol. 2008;26(29):4806-13.
7. Goldman JM. Ponatinib for chronic myeloid leukemia. N Engl J Med. 2012;367(22):2148-9.
8. Cortes J, Radich J, Mauro MJ. Clinical roundtable monograph: emerging treatment options for TKI-resistant chronic myelogenous leukemia. Clin Adv Hematol Oncol. 2012;10(10 Suppl 19):1-16.
9. Cortes JE, Kantarjian H, Shah NP, et al. Ponatinib in refractory Philadelphia chromosome-positive leukemias. N Engl J Med. 2012;367(22):2075-88.
10. Ariad Pharmaceuticals Inc. Iclusig® (ponatinib) tablets for oral use: prescribing information; 2013. http://www.accessdata.fda.gov/drugsatfda-docs/ label/2013/203469s007s008lbl.pdf. Accessed 11 April 2014.
11. O'Hare T, Shakespeare WC, Zhu X, et al. AP24534, a pan-BCR-ABL inhibitor for chronic myeloid leukemia, potently inhibits the T315I mutant and overcomes mutation-based resistance. Cancer Cell. 2009;16(5):401-12.
12. European Medicines Agency. Iclusig (ponatinib): summary of product characteristics; 2014. http://www.ema.europa.eu/docs/en-GB/document-library/ EPAR-Product-Information/human/002695/WC500145646.pdf. Accessed 11 April 2014.
13. Mauro MJ, Cortes JE, Kantarjian HM, et al. Safety and durability of ponatinib in patients with Philadelphia chromosome-positive (Ph+) leukemia: long-term follow-up of an ongoing phase I study [abstract no. 7063 plus poster]. J Clin Oncol. 2013;31(15 Suppl. 1).
14. Sonnichsen D, Dorer DJ, Cortes J, et al. Analysis of the potential effect of ponatinib on the QTc interval in patients with refractory hematological malignancies. Cancer Chemother Pharmacol. 2013;71(6):1599-607.
15. European Medicines Agency. Assessment report: Iclusig (ponatinib); 2013. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Public-assessment- report/human/002695/WC500145648.pdf. Accessed 11 April 2014.
16. Narasimhan NI, Dorer DJ, Niland K, et al. Effects of food on the pharmacokinetics of ponatinib in healthy subjects. J Clin Pharm Ther. 2013;38(6):440-4.
17. Narasimhan NI, Dorer DJ, Niland K, et al. Effects of ketoconazole on the pharmacokinetics of ponatinib in healthy subjects. J Clin Pharmacol. 2013;53(9):974-81.
18. Cortes JE, Kim D-W, Pinilla-Ibarz J, et al. A phase 2 trial of ponatinib in Philadelphia chromosome-positive leukemias. N Engl J Med. 2013;369(19):1783-96 (plus supplementary appendix).
19. Cortes JE, Kim D-W, Pinilla-Ibarz J, et al. Ponatinib in patients (pts) with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) resistant or intolerant to dasatinib or nilotinib, or with the T315I BCR-ABL mutation: 2-year follow-up of the PACE trial [abstract no. 650]. Blood. 2013;121(21).
20. Pinilla-Ibarz J, Cortes JE, Kim D-W, et al. Clinical impact of dose modification on response to ponatinib in patients with chronic phase chronic myeloid leukemia (CP-CML) [abstract no. 4007 plus poster]. Blood. 2013;122(21).
21. Deininger MW, Shah NP, Cortes JE, et al. Impact of baseline (BL) mutations, including low-level and compound mutations, on ponatinib response and end of treatment (EOT) mutation analysis in patients (Pts) with chronic phase chronic myeloid leukemia (CP-CML) [abstract no. 652]. Blood. 2013;122(21).
22. Hochhaus A, Kim D-W, Pinilla-Ibarz J, et al. Molecular responses with ponatinib in patients with Philadelphia chromosome positive (Ph+) leukemia: results from the PACE trial [abstract no. 3763 plus poster]. Blood. 2012;120(21).
23. Mauro MJ, Cortes JE, Kim D-W, et al. Multivariate analyses of the clinical and molecular parameters associated with efficacy and safety in patients with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) treated with ponatinib in the PACE trial [abstract no. 3747 plus poster]. Blood. 2012;120(21).
24. Cortes JE, Kim D-W, Pinilla-Ibarz J, et al. A pivotal phase 2 trial of ponatinib in patients with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) resistant or intolerant to dasatinib or nilotinib, or with the T315I BCR-ABL mutation: 12-month follow-up of the PACE trial [abstract no. 163 plus oral]. Blood. 2012;120(21).
25. Kantarjian HM, Kim D-W, Pinilla-Ibarz J, et al. Efficacy and safety of ponatinib in patients with accelerated phase or blast phase chronic myeloid leukemia (AP-CML or BP-CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL): 12-month follow-up of the PACE trial [abstract no. 915 plus oral]. Blood. 2012;120(21).
26. Ariad Pharmaceuticals. Ponatinib for chronic myeloid leukemia (CML) evaluation and Ph+ acute lymphoblastic leukemia (ALL) (PACE). [ClinicalTrials.gov identifier NCT01207440]. US National Institutes of Health, ClinicalTrials.gov [online]. 2013. http://clinicaltrials.gov/ct2/show/ NCT01207440?term=ponatinib&rank=7. Accessed 11 April 2014.
27. US Food and Drug Administration. FDA Drug Safety Communication: FDA requires multiple new safety measures for leukemia drug Iclusig; company expected to resume marketing; 2013. http://www.fda.gov/Drugs/DrugSafety/ ucm379554.htm. Accessed 11 April 2014.