International Journal of Hematology and Oncology
2023, Vol 33, Num 4 Page(s): 215-221
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Generic Imatinib Mesylate is as Effective as Original Glivec in the Clinical Management of CML
Umit Y. MALKAN1, Salih AKSU1, Sude H. AKTIMUR2, Hilmi ATAY2, Ozlen BEKTAS3, Yahya BUYUKASIK1, Haluk DEMIROGLU1, Eylem ELIACIK1, Mert ESME4, Abdullah HACIHANEFIOGLU5, Gursel GUNES1, Hakan GÖKER1, Sema KARAKUS6, Saadettin KILICKAP7, Ebru KOCA6, Osman I. OZCEBE1, Nilgun SAYINALP1, Pınar TARKUN5, Mehmet TURGUT2, Ibrahim C. HAZNEDAROGLU1*
1Hacettepe University, Faculty of Medicine, Department of Hematology, Ankara, TURKEY
2Ondokuz Mayis University, Faculty of Medicine, Department of Hematology, Samsun, TURKEY
3Konya Research and Training Hospital, Department of Hematology, Konya, TURKEY
4Hacettepe University, Faculty of Medicine, Department of Internal Medicine, Ankara, TURKEY
5Kocaeli University, Faculty of Medicine, Department of Hematology, Kocaeli, TURKEY
6Baskent University, Faculty of Medicine, Department of Hematology, Ankara, TURKEY
7Hacettepe University, Faculty of Medicine, Department of Oncology, Ankara, TURKEY
*On behalf of Turkish CML Study Group, TURKEY
Keywords: Generic, Imatinib, Glivec, Chronic Myeloid Leukemia
Unsustainable drug prices in chronic myeloid leukemia (CML) and cancer may be causing harm to patients. The aim of this multicenter study is to assess the efficacy of generic imatinib mesylate (IM) over Glivec in terms of hematological, cytogenetic, and molecular responses in CML. The data of 120 CML patients, who were treated with generic or original form of IM, were obtained from six different hematology clinics in Turkey between the years of 2009-2014 and analyzed retrospectively. Initial evaluation revealed that only one patient who was using original molecule switched to second generation tyrosine kinase inhibitor (TKI). In this period, hematological response(HR) was observed in 99.2% of the patients, cytogenetic response (CR) was observed in 88.7% of the patients (47 of 53), and molecular response (MR) was observed in 75% of the patients. Clinicians had a tendency to prefer generic molecules in each sequent visit, and this switch rate was statistically significant (p< 0.001). 11 patients, who were using original molecules during all cohorts, switched to second generation TKI. On the other hand, only one patient, who was using generic molecules, switched to second generation TKI. Our paper may help to clarify the doubts about the efficacy of generic IM compared to original molecule. In our study we did not find any significant difference in HR, CR, and MR for original and generic drugs in each visit. Herein, we find low rates of need to switch to second generation TKIs with generic IM and no difference in treatment responses between generic and original molecules that confirms the non-inferiority of generic TKIs over original molecules.
Umit Y. MALKAN1, Salih AKSU1, Sude H. AKTIMUR2, Hilmi ATAY2, Ozlen BEKTAS3, Yahya BUYUKASIK1, Haluk DEMIROGLU1, Eylem ELIACIK1, Mert ESME4, Abdullah HACIHANEFIOGLU5, Gursel GUNES1, Hakan GÖKER1, Sema KARAKUS6, Saadettin KILICKAP7, Ebru KOCA6, Osman I. OZCEBE1, Nilgun SAYINALP1, Pınar TARKUN5, Mehmet TURGUT2, Ibrahim C. HAZNEDAROGLU1*
1Hacettepe University, Faculty of Medicine, Department of Hematology, Ankara, TURKEY
2Ondokuz Mayis University, Faculty of Medicine, Department of Hematology, Samsun, TURKEY
3Konya Research and Training Hospital, Department of Hematology, Konya, TURKEY
4Hacettepe University, Faculty of Medicine, Department of Internal Medicine, Ankara, TURKEY
5Kocaeli University, Faculty of Medicine, Department of Hematology, Kocaeli, TURKEY
6Baskent University, Faculty of Medicine, Department of Hematology, Ankara, TURKEY
7Hacettepe University, Faculty of Medicine, Department of Oncology, Ankara, TURKEY
*On behalf of Turkish CML Study Group, TURKEY
Keywords: Generic, Imatinib, Glivec, Chronic Myeloid Leukemia
Unsustainable drug prices in chronic myeloid leukemia (CML) and cancer may be causing harm to patients. The aim of this multicenter study is to assess the efficacy of generic imatinib mesylate (IM) over Glivec in terms of hematological, cytogenetic, and molecular responses in CML. The data of 120 CML patients, who were treated with generic or original form of IM, were obtained from six different hematology clinics in Turkey between the years of 2009-2014 and analyzed retrospectively. Initial evaluation revealed that only one patient who was using original molecule switched to second generation tyrosine kinase inhibitor (TKI). In this period, hematological response(HR) was observed in 99.2% of the patients, cytogenetic response (CR) was observed in 88.7% of the patients (47 of 53), and molecular response (MR) was observed in 75% of the patients. Clinicians had a tendency to prefer generic molecules in each sequent visit, and this switch rate was statistically significant (p< 0.001). 11 patients, who were using original molecules during all cohorts, switched to second generation TKI. On the other hand, only one patient, who was using generic molecules, switched to second generation TKI. Our paper may help to clarify the doubts about the efficacy of generic IM compared to original molecule. In our study we did not find any significant difference in HR, CR, and MR for original and generic drugs in each visit. Herein, we find low rates of need to switch to second generation TKIs with generic IM and no difference in treatment responses between generic and original molecules that confirms the non-inferiority of generic TKIs over original molecules.
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