What is the role of fostamatinib in the treatment of immune thrombocytopenia (ITP) in adults?

Updated: Jan 11, 2020
  • Author: Craig M Kessler, MD, MACP; Chief Editor: Srikanth Nagalla, MBBS, MS, FACP  more...
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Answer

Fostamatinib (Tavalisse) was approved by the US Food and Drug Administration (FDA) in April 2018 for thrombocytopenia in adults with chronic ITP who have had an insufficient response to a previous treatment. It is the first spleen tyrosine kinase (SYK) inhibitor approved in the US. Approval was based on the FIT clinical program (n=163), which included 2 randomized placebo-controlled phase 3 trials and an open-label extension trial. [54]

In those randomized trials, more patients experienced a platelet response with fostamatinib than with placebo (18% vs 0% and 16% vs 4%). In the open-label expansion trial, 23% of patients who had received placebo in the previous randomized trials experienced a platelet response. Fewer bleeding episodes were observed in patients in the fostamatinib arm compared with placebo (29% vs 37%). Most of the patients who responded demonstrated durable platelet increments. [54]


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