Fostamatinib (1) – Tavlesse®

• Clinical trials
  • The randomised, controlled trials 047 and 048 were submitted for the assessment of the additional benefit of fostamatinib compared with the appropriate comparator therapy.
  • Both studies were double-blind, multicentre registration trials with an identical study design, in which treatment with fostamatinib was compared with placebo in adult patients with persistent or chronic immune thrombocytopenia who had received at least one prior treatment.

Adult patients with chronic immune thrombocytopenia who are refractory to other treatments

• An additional benefit is not proven.
• In summary, on the basis of the studies submitted, no conclusions can be drawn regarding the additional benefit of fostamatinib compared with the appropriate comparator therapy.
• Due to the failure to implement the appropriate comparator therapy, it is not possible to assess the additional benefit.
• Overall assessment
  • As the submitted placebo-controlled studies did not compare fostamatinib with the specified appropriate comparator therapy, these studies are not suitable for early benefit assessment.

Courtesy translation only, please refer to the German original.