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FDA Grants Frontline Eltrombopag Priority Review for Severe Aplastic Anemia

Jason M. Broderick @jasoncology
Published: Wednesday, May 30, 2018

Samit Hirawat, executive vice president and head, Global Drug Development at Novartis Oncology
Samit Hirawat
The FDA has granted a priority review to a supplemental new drug application (sNDA) for eltrombopag (Promacta) for use in combination with standard immunosuppressive therapy as a frontline treatment for patients with severe aplastic anemia (SAA), according to Novartis, the manufacturer of the oral thrombopoietin-receptor agonist.

Eltrombopag is currently approved for the treatment of patients with SAA who have an insufficient response to immunosuppressive therapy. It is also approved for the treatment of thrombocytopenia in adult and pediatric patients aged ≥1 year with chronic immune (idiopathic) thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Townsley DM, Scheinberg P, Winkler T, et al. Eltrombopag added to standard immunosuppression for aplastic anemia. N Engl J Med. 2017;376(16):1540-1550.  doi: 10.1056/NEJMoa1613878

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