Rigel Pharmaceuticals, Inc.,today announced that a paper presenting a post-hoc data analysis of TAVALISSE® (fostamatinib disodium hexahydrate) tablets, as well as accompanying commentary have been published in the British Journal of Haematology. TAVALISSE, Rigel's oral spleen tyrosine kinase (SYK) inhibitor, is indicated for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
"This post-hoc data analysis represents a potential paradigm shift in the treatment of adult patients with ITP following the use of a first-line treatment, predominantly steroids," stated Ralph Boccia, MD, Center for Cancer and Blood Disorders, Bethesda, Maryland and first author of the paper. "ITP is a heterogeneous disease that requires an individualized treatment approach. This data analysis offers clinicians a better understanding of the role of TAVALISSE, with its novel mechanism of action, as an alternative treatment early in the course of the disease."
Rigel conducted the post-hoc data analysis, which has previously been presented, from a Phase 3 clinical program of TAVALISSE in adult patients with ITP. The published data analysis and accompanying commentary highlight the higher response rate and decrease in bleeding incidents in ITP patients receiving TAVALISSE as a second-line therapy. In this analysis, 32 patients received fostamatinib as a second-line therapy, of which, 78% (25/32) achieved at least 1 platelet count of at least 50,000/µL while on treatment (without rescue therapy). Adverse events were manageable and consistent with those previously reported with fostamatinib.