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Generic imatinib non-inferior to Gleevec Posted 28/08/2015

Following the approval of four generics of imatinib in Turkey, Demirkan and co-authors from the Dokuz Eylül University in Turkey compared the efficacy of these newly approved generics with the originator product Gleevec from Novartis [1].

Tyrosine kinase inhibitors are the mainstay of treatment of chronic myeloid leukaemia (CML). The newly approved generics of imatinib were used as initial frontline therapy in a newly diagnosed chronic phase CML (CP-CML) in Turkey, with a saving of US$130 per box.

The study included 35 patients who were diagnosed as CP-CML between July 2011 and March 2013. Of the enrolled patients, 14 received generic imatinib and 21 received originator imatinib at a starting dose of 400 mg. Patients’ demographics, risk scores, side effects and imatinib response were recorded retrospectively. Haematologic, cytogenetic and molecular responses were compared among generics and originator groups.

The results of the study were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting ASCO 2015 held in Chicago, USA, on 29 May–2 June 2015.

The results showed that all patients were able to achieve a complete haematologic response at month 3. Complete cytogenetic response rates at month 6 were 57.1% and 52.6% for the generic group (A) and originator group (B), respectively (p = 0.530). Major molecular response rates at month 6 were 35.7% and 31.6% for group A and B, respectively (p = 0.721). Two patients in group A and 3 patients in group B were switched to a second generation tyrosine kinase inhibitor due to resistance (p = 0.679). Combined haematological and non-haematological adverse event rates were similar in both groups (28.6% and 33.3% for group A and B, respectively; p = 0.543).

There is very limited and conflicting data regarding the efficacy and tolerability of generic imatinib formulations. However, the authors concluded that among their patient cohort, ‘at a reasonably long-term follow-up, generic formulations were not inferior to the original imatinib regarding the efficacy and tolerability’.

Conflict of interest
The authors of the research paper [1] declared that there were no conflicts of interest.

Editor’s comment
It should be noted that data of the study presented in this article were published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

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1.  Demirkan F, Sevindik OGG, Karaman A, et al. Comparing the efficacy of generic Imatinib formulations with the original Imatinib as the frontline tyrosine kinase inhibitor in chronic phase chronic myeloid leukemia. ASCO 2015; 29 May–2 June 2015; Chicago, USA.

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