LONDON—SkyePharma PLC and its marketing partner, Chiron Corporation (Emeryville, California) have received clearance from the US Food and Drug Administration to return DepoCyt (cytarabine liposome injection) to the market.
DepoCyt is the only FDA-approved treatment for patients with lymphomatous meningitis, a potentially fatal complication of cancer that occurs when a patient’s primary cancer metastasizes to the membranes and cerebral spinal fluid surrounding the brain and spinal cord.
Chiron, which holds marketing rights for DepoCyt in the United States, 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, the companies said in a press release.
DepoCyt is an injectable, sustained-release formulation of cytarabine(Drug information on cytarabine). Using SkyePharma’s proprietary lipid-based drug delivery technology, DepoFoam, DepoCyt gradually releases cytarabine into the cerebral spinal fluid and extends the dosing interval to once every 2 weeks, as compared with the standard intrathecal chemotherapy dosing of twice a week.
The indication for DepoCyt is based on the demonstration, in a controlled study, of increased complete response rate, compared with standard unencapsulated intrathecal cytarabine (41% vs 6%, respectively). There are no controlled trials that demonstrate a clinical benefit resulting from DepoCyt treatment, such as improvement in disease-related symptoms, increased time to disease progression, or increased survival. ONI
