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Our publication in LEUKEMIA: Patients' declaration on the use of generics in CML treatment

2016-08-26 16 21 01-Leukemia - Chronic myeloid leukemia patients call for quality and consistency whMarket exclusivity for imatinib has lapsed in 10 EU countries, most countries to follow in 2016. CML patients have been increasingly exposed to generics and copy drugs in the treatment of CML, raising concerns about outcomes when patients are switched between products for non-medical reasons.

A survey of patient organisations and physicians by the CML Advocates Network in 2013 determined that generic imatinib and dasatinib were available in 32 countries. In 2014, CML patient organizations released a declaration, calling for quality and consistency when TKI generics are prescribed, demanding data on bioequivalence and clinical equivalence to the originator drug. Patients should not be switched between products with the same substance for non-medical reasons. If a switch is enforced, it should not happen more than once a year, with sufficient follow-up assessing safety and efficacy. In case of loss of response or increase in toxicity after switching, switching to the previous treatment or another treatment should be allowed. More frequent molecular monitoring post-switch should allow early detection of differences in effectiveness or toxicity. These recommendations by the patient community may support experts' discussion on CML management with TKI generics.

Our paper has now been published in the journal LEUKEMIA, doi: 10.1038/leu.2016.220

Abstract

Chronic myeloid leukemia patients call for quality and consistency when generics are introduced to treat their cancer

Leukemia, 26 August 2016; doi: 10.1038/leu.2016.220

Mr. Jan Geissler, Mr. Giora Sharf , Ms. Jelena Cugurovic , Mr. Rod Padua , Mr. Šarūnas Narbutas , Ms. Milena Remic , Ms. Viji Venkatesh

Imatinib is a tyrosine kinase inhibitor (TKI) used in the treatment of CML. Market exclusivity for imatinib has lapsed in 10 EU countries, most countries to follow in 2016. Patients have been increasingly exposed to generics and copy drugs in the treatment of CML, raising concerns about outcomes when patients are switched between products for non-medical reasons. A survey of patient organisations and physicians by the CML Advocates Network in 2013 determined that generic imatinib and dasatinib were available in 32 countries. In 2014, CML patient organizations released a declaration, calling for quality and consistency when TKI generics are prescribed, demanding data on bioequivalence and clinical equivalence to the originator drug. Patients should not be switched between products with the same substance for non-medical reasons. If a switch is enforced, it should not happen more than once a year, with sufficient follow-up assessing safety and efficacy. In case of loss of response or increase in toxicity after switching, switching to the previous treatment or another treatment should be allowed. More frequent molecular monitoring post-switch should allow early detection of differences in effectiveness or toxicity. These recommendations by the patient community may support experts' discussion on CML management with TKI generics.

Full text (HTML): http://www.nature.com/leu/journal/vaop/ncurrent/full/leu2016220a.html
Full text for download (PDF): http://www.nature.com/leu/journal/vaop/ncurrent/pdf/leu2016220a.pdf

 


 
   
 

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