FDA grants full approval for Enzon meningitis drug

DepoCyt was originally approved under an accelerated approval regulation, based on a preliminary demonstration of an increased complete response rate compared to the chemotherapy drug cytarabine.

DepoCyt is a sustained release formulation of cytarabine, used for patients with lymphomatous meningitis. Because of the cytarabine’s short half-life, a spinal injection is required twice per week, whereas DepoCyt is dosed once every two weeks. DepoCyt is manufactured by SkyePharma.

The full approval was based on findings from two clinical trials that included patients with neoplastic meningitis related to solid tumors, lymphoma or leukemia. The first study demonstrated that more patients with lymphomatous meningitis treated with DepoCyt showed an absence of neurological progression of the disease. The second study showed an increase in complete cytologic responses among patients treated with DepoCyt, as defined by a clearing of malignant cells in the cerebrospinal fluid.

“The FDA’s full approval of DepoCyt is an important milestone for this unique product that has benefited those suffering from this devastating complication of cancer since its introduction to the market in 1999,” said Jeffrey Buchalter, chairman and CEO of Enzon.