Clinical efficacy of generic imatinib

Journal of Oncology Pharmacy Practice

Volumn 21, Issue 1, 2015, Pages 76-79

  De Lemos, Mario L ^a   Kyritsis, Victoria ^a  

^a BRITISH COLUMBIA CANCER AGENCY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA CRYSTALLIN; BETA CRYSTALLIN; GENERIC DRUG; IMATINIB; ANTINEOPLASTIC AGENT; BENZAMIDE DERIVATIVE; PIPERAZINE DERIVATIVE; PYRIMIDINE DERIVATIVE;

ADULT; BIOEQUIVALENCE; CANADA; CASE STUDY; CHILD; CHILDHOOD LEUKEMIA; CHRONIC MYELOID LEUKEMIA; CLINICAL EFFECTIVENESS; DRUG ABSORPTION; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG USE; DUODENUM; EMBASE; EUROPEAN MEDICINES AGENCY; EUROPEAN UNION; GASTRECTOMY; GASTROINTESTINAL TUMOR; GROUPS BY AGE; HUMAN; ILEUM; JEJUNUM; MEDICAL INFORMATION; MEDLINE; REVIEW; ROOM TEMPERATURE; STOMACH BYPASS; STOMACH PH; LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE; TREATMENT OUTCOME;

ADULT; ANTINEOPLASTIC AGENTS; BENZAMIDES; CHILD; DRUGS, GENERIC; HUMANS; LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE; PIPERAZINES; PYRIMIDINES; TREATMENT OUTCOME;

EID: 84920520396     PISSN: 10781552     EISSN: 1477092X     Source Type: Journal    
DOI: 10.1177/1078155214522143     Document Type: Review

References (29)

1. Teva Canada Ltd. TEVA-IMATINIB® product monograph. ON, Canada, 28 March 2013.
2. Apotex Inc. APO-IMATINIB® product monograph. Toronto, ON, Canada, 4 June 2013.
3. European Medicines Agency. Assessment Report-Imatinib Teva. London, UK, 18 October 2012.
4. European Medicines Agency. Assessment Report-Imatinib Actavis. London, UK, 21 February 2013.
5. European Medicines Agency. Assessment Report-Imatinib Accord. London, UK, 25 April 2013.
6. Goubran HA. Failure of a non-authorized copy product to maintain response achieved with imatinib in a patient with chronic phase chronic myeloid leukemia: a case report. J Med Case Rep. 2009 ; 3: 7112-7112
7. Asfour IA, Elshazly SA. Changing therapy from Glivec to a "copy" imatinib results in a worsening of chronic myeloid leukemia disease status: two case reports. Case J. 2009 ; 2: 9342-9342
8. Chouffai Z. Hematologic relapse after 2 years on a non-authorized copy version of imatinib in a patient with chronic myeloid leukemia in chronic phase: a case report. Case Rep Oncol. 2010 ; 3: 272-276
9. Mattar M. Failure of copy Imatib (CIPLA, India) to maintain hematologic and cytogenetic responses in chronic myeloid leukemia in chronic phase. Int J Hematol. 2010 ; 91: 104-106
10. Razmkhah F, Razavi M, Zaker F, et al. Hematologic and molecular responses to generic imatinib in patients with chronic myeloid leukemia. Lab Med. 2010 ; 41: 547-550
11. Alwan A, Alshami A, Hatim A, et al. Impact of switching therapy from imatinib mesylate to generic copy of imatinib on hematologic response in patients with chronic phase chronic myeloid leukemia: single center study. Presented at: The Congress of the European hematology association, London, UK, 11 June 2011, abstract 1219.
12. Chronic Myelogenous Leukemia Society of Canada. Generic tyrosine kinase inhibitors (TKIs) arrive in Canada. Chronic Myelogenous Leukemia Society of Canada, Undated, http://cmlsociety.org/generic-tyrosine-kinase-inhibitors-tkis-arrive-in-canada/ (accessed 6 January 2014)..
13. GIS-GIST Support International. Generic Gleevec. GIS-GIST Support International, 20 December 2013, http://gistsupport.medshelf.org/Generic-Gleevec (accessed 6 January 2014).
14. Parrillo-Campiglia S, Ercoli MC, Umpierrez O, et al. Bioequivalence of two film-coated tablets of imatinib mesylate 400 mg: a randomized, open-label, single-dose, fasting, two-period, two-sequence crossover comparison in healthy male South American volunteers. Clin Ther. 2009 ; 31: 2224-2232
15. Jawhari D, Alswisi M, Ghannam M. Bioavailability of a new generic formulation of imatinib mesylate 400 mg tablets versus glivec in healthy male adult volunteers. J Bioequiv Availab. 2011 ; 3: 161-164
16. Gogtay J, Chahchad S, Jadhav S, et al. Response to the case report by Mattar: Generic Imatinib (Imatib, Cipla) in a patient with chronic myeloid leukemia in chronic phase. Int J Hematol. 2010 ; 92: 772-773
17. Cipla. IMATIB® product monograph. Mumbai, India, July 2012.
18. Novartis Pharmaceuticals Canada Inc. GLEEVEC® product monograph. Dorval, QC, Canada, 17 February 2011.
19. Dagher R, Cohen M, Williams G, et al. Approval summary: imatinib mesylate in the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumors. Clin Cancer Res. 2002 ; 8: 3034-3038
20. Peng B, Lloyd P, Schran H. Clinical pharmacokinetics of imatinib. Clin Pharmacokinet. 2005 ; 44: 879-894
21. Liu H, Artz AS. Reduction of imatinib absorption after gastric bypass surgery. Leuk Lymphoma. 2011 ; 52: 310-313
22. Pavlovsky C, Egorin MJ, Shah DD, et al. Imatinib mesylate pharmacokinetics before and after sleeve gastrectomy in a morbidly obese patient with chronic myeloid leukemia. Pharmacotherapy. 2009 ; 29: 1152-1156
23. Yamazaki R, Aisa Y, Mori T, et al. Administration of imatinib mesylate in patients with chronic myeloid leukemia with short bowel. Leuk Lymphoma. 2009 ; 50: 670-672
24. European Medicines Agency. Scientific Discussion - Glivec. London, UK; 1 September 2004.
25. Sparano BA, Egorin MJ, Parise RA, et al. Effect of antacid on imatinib absorption. Cancer Chemother Pharmacol. 2009 ; 63: 525-528
26. Egorin MJ, Shah DD, Christner SM, et al. Effect of a proton pump inhibitor on the pharmacokinetics of imatinib. Br J Clin Pharmacol. 2009 ; 68: 370-374
27. Judgment of the Supreme Court of India. Novartis AG v Union of India and Ors, 1 April 2013. http://judis.nic.in/supremecourt/chejudis.asp (accessed 2 August 2013).
28. Grillo D, Polla G, Vega D. Conformational polymorphism on imatinib mesylate: grinding effects. J Pharm Sci. 2012 ; 101: 541-551
29. Anonymous. Guidance for Industry. ANDAs: pharmaceutical solid polymorphism, chemistry, manufacturing, and controls information. Rockville, MD: Center for Drug Evaluation and Research, Food and Drug Administration, U.S. Department of Health and Human Services, July 2007.