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Ruxolitinib Granted Priority Review for Polycythemia Vera

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The U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi) as a potential treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.

The Prescription Drug User Fee Act date for the sNDA for ruxolitinib is set for December 5, 2014.

Polycythemia vera is a myeloproliferative neoplasm characterized by an overproduction of normal red blood cells, white blood cells, and platelets. Patients with uncontrolled polycythemia vera have an increased risk of cardiovascular complications such as stroke, pulmonary embolism, deep-vein thrombosis, and heart attack. Of the approximately 100,000 patients with polycythemia vera in the United States, 25% develop resistance to or intolerance of hydroxyurea and are considered uncontrolled.

The sNDA included results from the phase III RESPONSE trial, which found that ruxolitinib was well tolerated and superior to best available therapy in controlling hematocrit without phlebotomy, a key therapeutic goal, and reducing splenomegaly in polycythemia vera patients resistant to or intolerant of hydroxyurea. Ruxolitinib was also effective in improving polycythemia vera–associated symptoms.

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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