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FDA Approves Fostamatinib Disodium Hexahydrate for Chronic Immune Thrombocytopenia in Adult Patients

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On April 17, the U.S. Food and Drug Administration (FDA) approved fostamatinib disodium hexahydrate (Tavalisse) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.

Fostamatinib is an oral spleen tyrosine kinase inhibitor that targets the underlying autoimmune cause of the disease by impeding platelet destruction, providing an important new treatment option for adult patients with chronic immune thrombocytopenia.  

Rigel plans to launch fostamatinib in the United States in late May 2018. 

Treatment Challenge

“Chronic [immune thrombocytopenia] is challenging to treat, because the heterogeneity of the disease makes it difficult to predict how an individual patient will respond to available treatments, and not all patients can find a treatment that works well for them,” said James Bussel, MD, Professor Emeritus of Pediatrics at Weill Cornell Medicine and the principal study investigator on the FIT phase III program. “The FDA approval of fostamatinib arms physicians with a new treatment option, which works via a novel mechanism.”

The FDA approval of fostamatinib was supported by data from the FIT clinical program, which included two randomized placebo-controlled phase III trials (studies 047 and 048) and an open-label extension (study 049), as well as an initial proof-of-concept study. The new drug application included data from 163 patients with immune thrombocytopenia and was supported by a safety database of more than 4,600 subjects across other indications in which fostamatinib has been evaluated.

“People living with chronic [immune thrombocytopenia] often feel they have an invisible disease—one that can not only impact quality of life, but also be life-threatening,” said Caroline Kruse, Executive Director of the Platelet Disorder Support Association, a patient advocacy organization dedicated to immune thrombocytopenia patients. “That's why we encourage members of our community to learn about their disease, understand treatment strategies, and seek support so that they can advocate for their best care. The availability of a new treatment option provides the [immune thrombocytopenia] community with more choices.”

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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