Lymphoma
FDA Grants Full Approval for DepoCyt for the Treatment of Lymphomatous Meningitis
Published in TB and Outbreaks Week, May 8th, 2007
Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced that the US Food and Drug Administration (FDA) has granted full approval for DepoCyt(R) (cytarabine liposome injection) for the treatment of patients with lymphomatous meningitis, a life-threatening complication of lymphoma. DepoCyt was originally approved under the Accelerated Approval regulations of Subpart H of the Food, Drug and Cosmetic Act, based on a preliminary demonstration of an increased complete response rate compared to unencapsulated cytarabine.
The full approval was based on findings from two randomized controlled clinical trials that included over 200 patients with neoplastic meningitis related...
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