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‘Real-life’ registry findings support generic imatinib efficacy

medwireNews: Initial research suggests that two generic forms of imatinib may not be inferior to the branded version of the tyrosine kinase inhibitor (TKI) for the treatment of patients with chronic myeloid leukaemia in the chronic phase (CML).
Tomasz Sacha, from Jagiellonian University Hospital in Krawow, Poland, reported 1-year observational findings for 726 patients entered into the Polish Imatinib Generics Registry at the European Hematology Association congress in Copenhagen, Denmark.
This included 92 patients who had begun de novo treatment with the generic agents nibix (n=62), meaxin (n=24) or other generics (n=6), and 591 patients who had switched from the branded agent Glivec to generic nibix (n=445) or meaxin (n=146).
For the de novo patients, there was no significant difference in the likelihood of early molecular response to treatment, defined as of less than 10% at 3 months, between the three treatment groups. Nor was there a significant difference in the rate of BCR–ABL to less than 1% at the 6-month checkpoint.
And among patients who switched to a generic agent, there was no significant difference in

Using CTCAE criteria
Rate of grade 3–4 haematologial grade adverse events
Rate of all-grade non-haematological adverse events 

By Lynda Williams, Senior medwireNews Reporter
medwireNews (www.medwireNews.com) is an independent medical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2016
European Hematology Association 21st Congress; Copenhagen, Denmark: 9–12 June 2016
Meeting website http://www.ehaweb.org/congress-and-events/21st-congress/key-information-3/