Generic Version Yields Similar Efficacy, Safety to Imatinib in CML-CP
Results from a prospective study in India show that the generic version of imatinib yields similar efficacy and safety, with lower cost, in patients with chronic myeloid leukemia in chronic-phase (CML-CP).
“In India, CML is the commonest adult leukemia. Imatinib is the gold standard for frontline treatment of newly diagnosed CML-CP patients. The present study was conducted to assess the efficacy and safety of generic imatinib in newly diagnosed CML-CP patients,” writes Abhijit Phukan, MD, Department of Hematology, NRS Medical College, Kolkata, India, and colleagues
A total of 76 patients participated in this study, each one receiving generic imatinib and being monitored as per the ELN2013 recommendation. Patients also underwent karyotyping and BCR-ABL transcript level at specified time points.
Three months into taking generic imatinib, 64.5% of patients achieved an early molecular response. After 6 months, 65% of patients saw complete cytogenetic response and 68% saw major cytogenetic response. By 12 months, major molecular response was noted in 44% of cases.
The most common symptom was fatigue, which was present in 71% of patients, splenomegaly was found in all. Anemia was the most common hematologic toxicity, being found in 89.5% of patients, and skin changes were the most common non-hematologic toxicity, found in 71% of patients.
“With generic imatinib therapy, the results of treatment outcome and safety profile were comparable with original imatinib. The added advantage was gross reduction in cost of therapy meeting unmet needs in CML patients in countries with resource constraints,” concluded Dr Phukan et al. —Alexandra Graziano
