Spotlight: Archives

Every month, the subjects in Prescrire’s Spotlight.

2021 : 1 | 30 | 60

In the January issue of Prescrire International: Dasatinib (Sprycel° and other brands) in children with acute lymphoblastic leukaemia

FREE DOWNLOAD Dasatinib has been granted marketing authorisation in the European Union as first-line therapy added to chemotherapy for children with Philadelphia chromosome-positive acute lymphoblastic leukaemia.
Full text available for free download.

Key points

  • The application to obtain marketing authorisation for dasatinib in this situation was based on data from a non-comparative trial. Additional data have become available from a randomised, non-blinded, head-to-head trial of dasatinib versus imatinib, added to chemotherapy, but bias in the comparison weakens the quality of the evidence.
     
  •  NOTHING NEW  Bias in the comparison with imatinib makes the favourable results obtained for dasatinib impossible to intepret. More than two years after its authorisation, the oral liquid form of dasatinib, for children unable to swallow tablets, is still not marketed in France. 
     
  •  EDITORS' OPINION  Failure to demand solid evidence for marketing authorisation spells danger for patients. In March 2020, the EMA rightly urged the scientific community to conduct randomised comparative trials designed to generate robust evidence on covid-19. It would be helpful if the EMA adopted the same attitude towards other clinical situations, to better serve patients and build confidence in its work. 

©Prescrire 1 January 2021

Source: "Dasatinib (Sprycel° and other brands) in children with acute lymphoblastic leukaemia" Prescrire International 2021; 30 (222): 12-13. Free.

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See also:

"Failure to demand solid
evidence for marketing
authorisation spells
danger for patients"
Prescrire Int 2021;
30 (222): 13.
Pdf, free


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