Contributions
Abstract: PB1908
Type: Publication Only
Background
The development of oral well tolerated bcr-abl tyrosine kinase inhibitor (TKI) has revolutionized the treatment of chronic myeloid leukemia (CML) and allowed thousands of patients over the past 15 years to live healthy and productive. Generic imatinib is already available in a number of countries, the use of generic is expected to lower the cost of CML therapy however the data regarding their efficacy and tolerability in larger populations of CML patients are lacking. In January 2015 Health Tunisia approved CEMIVIL, a generic of imatinib, manufactured by HIKMA Pharmaceutical.
Aims
The aim of this study was to evaluate the efficacy and tolerability of imatinib generic in Tunisian patients suffering from chronic phase CML.
Methods
In this retrospective analysis data from patients with frontline cemivil between January 2015 and December 2017 is included .we report the rate of bcr-abl/abl reduction to < 10% at 3 months and to < 1% at 6 months of therapy, the rate of optimal response and failure according to current ELN guidelines, the rate of MMR, MR4 and MR4.5 achieved at 12 months of therapy and the rate of patients switched to second generation TKI have been assessed.
Results
Between January 2015 and December 2017, 51 patients started do novo treatment with generic. Early molecular remission defined by bcr-abl/abl ratio < 10% at 3 months was achieved in 83 %, bcr-abl/abl ratio< 1% at 6 months in 89% of patients. At 12 months of therapy 13 patients (25%) achieved RM4 and 5 patients (9%) achieved RM4.5.
14 Patients (27%) have been switched to second generation TKI, 2 patients due to intolerance, 8 patients due to resistance and 4 patients due to progression.
Conclusion
The findings of the present study showed comparable efficacy and safety of Cemivil in the treatment of patients with CML. The arrival of generic imatinib at a reduced price has the potential to markedly impact the cost of care for CML. It may also increase the access of patients to this remarkable drug that has previously been unaffordable to some.
Session topic: 7. Chronic myeloid leukemia – Biology & Translational Research
Keyword(s): Generic drugs, imatinib
Abstract: PB1908
Type: Publication Only
Background
The development of oral well tolerated bcr-abl tyrosine kinase inhibitor (TKI) has revolutionized the treatment of chronic myeloid leukemia (CML) and allowed thousands of patients over the past 15 years to live healthy and productive. Generic imatinib is already available in a number of countries, the use of generic is expected to lower the cost of CML therapy however the data regarding their efficacy and tolerability in larger populations of CML patients are lacking. In January 2015 Health Tunisia approved CEMIVIL, a generic of imatinib, manufactured by HIKMA Pharmaceutical.
Aims
The aim of this study was to evaluate the efficacy and tolerability of imatinib generic in Tunisian patients suffering from chronic phase CML.
Methods
In this retrospective analysis data from patients with frontline cemivil between January 2015 and December 2017 is included .we report the rate of bcr-abl/abl reduction to < 10% at 3 months and to < 1% at 6 months of therapy, the rate of optimal response and failure according to current ELN guidelines, the rate of MMR, MR4 and MR4.5 achieved at 12 months of therapy and the rate of patients switched to second generation TKI have been assessed.
Results
Between January 2015 and December 2017, 51 patients started do novo treatment with generic. Early molecular remission defined by bcr-abl/abl ratio < 10% at 3 months was achieved in 83 %, bcr-abl/abl ratio< 1% at 6 months in 89% of patients. At 12 months of therapy 13 patients (25%) achieved RM4 and 5 patients (9%) achieved RM4.5.
14 Patients (27%) have been switched to second generation TKI, 2 patients due to intolerance, 8 patients due to resistance and 4 patients due to progression.
Conclusion
The findings of the present study showed comparable efficacy and safety of Cemivil in the treatment of patients with CML. The arrival of generic imatinib at a reduced price has the potential to markedly impact the cost of care for CML. It may also increase the access of patients to this remarkable drug that has previously been unaffordable to some.
Session topic: 7. Chronic myeloid leukemia – Biology & Translational Research
Keyword(s): Generic drugs, imatinib