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| |  DepoCyt (Cytarabine Liposome Injection) Returned To US Market For Lymphomatous Meningitis EMERYVILLE, CA and LONDON, UK -- March 2, 2001 -- SkyePharma PLC and SkyePharma's marketing partner, Chiron Corporation announced that they have received clearance from the U.S. Food and Drug Administration (FDA) to return DepoCyt® (cytarabine liposome injection) to the market. DepoCyt is the only FDA approved treatment for patients with lymphomatous meningitis, a serious disabling and potentially fatal complication of cancer. Chiron holds marketing rights for DepoCyt in the United States. Chiron and SkyePharma voluntarily withdrew DepoCyt from the market in October 1999. Upon routine stability testing, it was discovered that certain batches of DepoCyt did not meet all regulatory specifications. There were no adverse events attributed to the recalled batches. DepoCyt is an injectable, sustained-release formulation of the chemotherapeutic agent, cytarabine. Using SkyePharma's proprietary lipid-based drug delivery technology, DepoFoam™, DepoCyt gradually releases cytarabine into the cerebral spinal fluid (CSF) and extends the dosing interval to once every two weeks as compared to the standard intrathecal chemotherapy dosing of two times per week. "We are delighted to bring this most important product back to the market," said Michael Ashton, chief executive officer of SkyePharma. "Manufacturing issues have been resolved by a combined effort with our partner, Chiron, truly highlighting the value of this joint venture between our two companies." "By providing continuous delivery of cytarabine over a two week period, DepoCyt offers patients the advantages of fewer injections and less frequent hospital visits," said Maurice Wolin, M.D., vice president of oncology development for Chiron. "We are pleased to be making this important treatment available to patients in need." A controlled, open-label, multi-center study showed that treatment with DepoCyt resulted in a 41 percent response rate versus a 6 percent response rate with standard cytarabine in patients with lymphomatous meningitis. Patients were considered responders when no cancer cells remained in the cerebral spinal fluid (CSF) and there was an absence of progression of neurologic symptoms. As expected with standard intrathecal chemotherapy, the most documented side effect from DepoCyt was arachnoiditis, an inflammation of the covering of the brain and spinal cord that causes symptoms such as headache, nausea, vomiting and fever. This side effect was generally transient and reversible and did not lead to missed treatments. Patients receiving DepoCyt should be treated concurrently with dexamethasone to reduce the incidence and severity of arachnoiditis. Lymphomatous meningitis is a condition that occurs when a patient's primary cancer metastasizes or spreads, by way of malignant cells, to the membranes and CSF surrounding the brain and spinal cord. Current incidence figures from the Lymphoma Research Foundation state that 7 to 15 percent of individuals with lymphoma, or approximately 6,000 people per year are diagnosed with lymphomatous meningitis. However, many patients remain undiagnosed due to the disease's wide-ranging symptoms. If left untreated, patients usually die within four to six weeks. Related Link: DepoCyt (cytarabine liposome injection).
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