Nilotinib: In the first-line treatment of newly diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase

Drugs

Volumn 71, Issue 12, 2011, Pages 1579-1590

  Garnock Jones, Karly P ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

Adis Drug Profiles; Chronic myeloid leukaemia; Nilotinib

Indexed keywords

IMATINIB; KETOCONAZOLE; NILOTINIB;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; AMYLASE BLOOD LEVEL; ANEMIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; CHRONIC MYELOID LEUKEMIA; CREATININE BLOOD LEVEL; DIARRHEA; DRUG DOSE INCREASE; DRUG EFFECT; DRUG EFFICACY; DRUG MECHANISM; DRUG METABOLISM; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EYELID EDEMA; FATIGUE; GLUCOSE BLOOD LEVEL; HEADACHE; HUMAN; HYPERKALEMIA; HYPOCALCEMIA; HYPOKALEMIA; HYPONATREMIA; HYPOPHOSPHATEMIA; META ANALYSIS (TOPIC); MUSCLE SPASM; MYALGIA; NAUSEA; NEUTROPENIA; NONHUMAN; PERIORBITAL EDEMA; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHILADELPHIA 1 CHROMOSOME; PHOSPHATE BLOOD LEVEL; PRURITUS; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; RECOMMENDED DRUG DOSE; SIDE EFFECT; SUDDEN DEATH; SYSTEMATIC REVIEW (TOPIC); THROMBOCYTOPENIA; TREATMENT OUTCOME; TRIACYLGLYCEROL LIPASE BLOOD LEVEL; VOMITING;

ANTINEOPLASTIC AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; HUMANS; LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE; PHILADELPHIA CHROMOSOME; PYRIMIDINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TIME FACTORS; TREATMENT OUTCOME;

EID: 80052013043     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.2165/11207770-000000000-00000     Document Type: Article

References (28)

1. Weisberg E, Manley P, Mestan J, et al. AMN107 (nilotinib): a novel and selective inhibitor of BCR-ABL. Br J Cancer 2006 Jun 19; 94 (12): 1765-9 (Pubitemid 43882564)
2. Faderl S, Talpaz M, Estrov Z, et al. The biology of chronic myeloid leukemia. N Engl J Med 1999 Jul 15; 341 (3): 164-72 (Pubitemid 29325745)
3. Mahon FX, Hayette S, Lagarde V, et al. Evidence that resistance to nilotinib may be due to BCR-ABL, Pgp, or Src kinase overexpression. Cancer Res 2008 Dec 1; 68 (23): 9809-16
4. Baccarani M, Dreyling M. Chronic myelogenous leukemia: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol 2009; 20 Suppl. 4: iv105-7
5. Deininger M, O'Brien SG, Guilhot F, et al. International randomized study of interferon vs STI571 (IRIS) 8-year follow up: sustained survival and low risk for progression or events in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) treated with imatinib [abstract no. 1126]. Blood 2009; 114 (22): 462
6. Wei G, Rafiyath S, Liu D. First-line treatment for chronic myeloid leukemia: dasatinib, nilotinib, or imatinib [online]. J Hematol Oncol 2010; 3: 47. Available from URL: http://www.jhoonline.org/content/pdf/1756-8722-3-47.pdf [Accessed 2011 Jul 15]
7. Radich JP. Chronic myeloid leukemia 2010: where are we now and where can we go? Hematology Am Soc Hematol Educ Program 2010; 2010: 122-8
8. Novartis Pharmaceuticals Corporation. Tasigna-(nilotinib capsules): US prescribing information [online]. Available from URL: http://www.pharma.us. novartis.com/product/pi/pdf/tasigna.pdf [Accessed 2011 Apr 15]
9. European Medicines Agency. Tasigna (nilotinib capsules): EU summary of product characteristics [online]. Available from URL: http://www.ema.europa.eu/ docs/en-GB/docu ment-library/EPAR-Product Information/human/0007 98/WC500034394.pdf [Accessed 2011 Apr 15]
10. Plosker GL, Robinson DM. Nilotinib. Drugs 2008; 68 (4): 449-59 (Pubitemid 351342015)
11. Weisberg E, Manley PW, Breitenstein W, et al. Characterization of AMN107, a selective inhibitor of native and mutant Bcr-Abl. Cancer Cell 2005 Feb; 7 (2): 129-41 (Pubitemid 40248339)
12. Golemovic M, Verstovsek S, Giles F, et al. AMN107, a novel aminopyrimidine inhibitor of Bcr-Abl, has in vitro activity against imatinib-resistant chronic myeloid leukemia. Clin Cancer Res 2005 Jul 1; 11 (13): 4941-7 (Pubitemid 41557215)
13. Manley PW, Drueckes P, Fendrich G, et al. Extended kinase profile and properties of the protein kinase inhibitor nilotinib. Biochim Biophys Acta 2010 Mar; 1804 (3): 445-53
14. Larson RA, Hochhaus A, Saglio G, et al. Cardiac safety profile of imatinib and nilotinib in patients (pts) with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP): results from ENESTnd [abstract no. 2291]. Blood 2010 Dec 4; 116 (21)
15. European Medicines Agency. Assessment report for Tasigna (nilotinib) [online]. Available from URL: http://www.ema. europa.eu/docs/en-GB/document- library/EPAR-Assess ment-Report-Variation/human/000798/WC500100775. pdf [Accessed 2011 May 9]
16. Le Coutre P, Hino M, Nobile F, et al. Results from ENESTnd: population pharmacokinetic (PK) and exposure-response analysis of nilotinib in patients with newly diagnosed PH+ chronic myeloid leukemia in chronic phase (CML-CP) [abstract no. 0146]. Haematologica 2010; 95 Suppl. 2: 59
17. Tanaka C, Yin OQ, Sethuraman V, et al. Clinical pharmacokinetics of the BCR-ABL tyrosine kinase inhibitor nilotinib. Clin Pharmacol Ther 2010 Feb; 87 (2): 197-203
18. Bouchet S, Chauzit E, Moore N, et al. Therapeutic drug monitoring of nilotinib: first data. Fundam Clin Pharmacol 2010; 24 Suppl. 1: 50-1
19. Yin OQ, Gallagher N, Tanaka C, et al. Effects of hepatic impairment on the pharmacokinetics of nilotinib: an openlabel, single-dose, parallel-group study. Clin Ther 2009; 31 Pt 2: 2459-69
20. Saglio G, Kim DW, Issaragrisil S, et al. Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. N Engl J Med 2010 Jun 17; 362 (24): 2251-9. Plus supplementary material available from URL: http://www.nejm. org [Accessed 2011 Apr 20]
21. Novartis Pharmaceuticals. A study of imatinib versus nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) (ENESTnd) [Clinical-Trials.gov identifier NCT00471497]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://www.clinicaltrials.gov [Accessed 2011 Jul 28]
22. Larson RA, Kim D, Rosti G, et al. Comparison of nilotinib and imatinib in patients (pts) with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP): ENESTnd 24-month follow-up [abstract no. 6511]. J Clin Oncol 2011 May; 29 (15 Suppl.)
23. Hochhaus A, Saglio G, Larson RA, et al. Nilotinib lowers the incidence of BCR-ABL mutations and improves the molecular response kinetics compared with imatinib in patients (pts) with newly diagnosed chronic myeloid leukemia (CML) [abstract no. 3431]. Blood 2010 Dec 4; 116 (21)
24. Beaumont JL, Coombs J, Bollu V, et al. Hospitalizations of patients with newly diagnosed CML-CP treated with nilotinib or imatinib: results from a randomized phase III trial [abstract no. 3826]. Blood 2010 Dec 4; 116 (21)
25. Conneally E, Swords RT, Giles FJ, et al. Nilotinib 300mg twice daily as first-line treatment of Ph-positive chronic myeloid leukemia in chronic phase: updated results of the ICORG 0802 phase 2 study with analysis of the GeneXpert system versus IS BCR-ABL RQ-PCR [abstract no. 3427]. Blood 2010; 116 (21)
26. Rosti G, Castagnetti F, Gugliotta G, et al. Excellent outcomes at 3 years with nilotinib 800 mg daily in early chronic phase, Ph+ chronic myeloid leukemia (CML): results of a phase 2 GIMEMA CML WP clinical trial [abstract no. 359]. Blood 2010 Dec 4; 116 (21)
27. Cortes JE, Jones D, O'Brien S, et al. Nilotinib as front-line treatment for patients with chronic myeloid leukemia in early chronic phase. J Clin Oncol 2010 Jan 20; 28 (3): 392-7
28. US National Institutes of Health. ClinicalTrials.gov [online]. Available from URL: http://www.clinicaltrials.gov [Accessed 2011 May 4]