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CML patient group calls for generic TKI use guidelines


Leukemia 2016; advance online publication


medwireNews: A worldwide network of nonprofit organisations supporting patients with chronic myeloid leukaemia (CML) and their families has made key recommendations to address concerns regarding the use of generic forms of tyrosine kinase inhibitors (TKIs).

The advice from the CML Advocates Network is designed to minimise “potential uncertainties and risks” of generic agents and is outlined in a letter to Leukemia aimed at governments, health authorities and healthcare professionals.

“The recommendations from the patient community may provide a basis for discussion by the expert groups for publishing treatment guidelines and recommendations for the management of CML”, say Jan Geissler, from Leukemia Patient Advocates Foundation in Bern, Switzerland, and co-authors.

The CML Advocates Network recommends that patients should not be given a generic TKI without “reliable proof of quality as well as bioequivalence (equivalent bioavailability/pharmacokinetics) to the originator drug”.

As well as initial approval by the relevant country or regional authorities, regulatory bodies should require further comparative clinical data on generic TKIs, the guidelines say.

The Network also recommends that patients with an optimal response to treatment should not be switched between different forms of the same agent for nonmedical reasons.

Indeed, the authors emphasize that where such a switch occurs, TKIs should not be changed more than once a year and that patients should have sufficient follow-up to ensure continuing drug response, including more frequent molecular monitoring to allow early detection of possible differences in efficacy or side effects.

“If a patient experiences loss of drug response or experiences a significant increase in toxicity after switching to another product containing the same active substance, the patient must have the option to return to the previous treatment or switch to another treatment, if available”, they write.

In 2013, the CML Advocates Network sent out a questionnaire to 80 patient advocacy groups regarding the use of generic agents and received 86 responses from 55 countries. Information from the survey was then used to form a discussion at the annual CML global advocacy meeting in Belgrade, Serbia in 2014.

The need for guidelines was noted following reports of loss of efficacy after switching to a generic formulation and the concern that some countries authorise generic agents on the basis of in vitro tests, without clinical demonstration of bioequivalence.

By the 2014 meeting, generic imatinib or dasatinib were available in 32 different countries including sites in North and South American, Asia, Africa and Europe.


By Lynda Williams, Senior medwireNews Reporter

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