SkyePharma PLC and Chiron Corporation have received clearance from the US Food and Drug Administration (FDA) to return cytarabine liposome injection (DepoCyt) to the market. Liposomal cytarabine is the only FDA-approved treatment for
SkyePharma PLC and ChironCorporation have received clearance from the US Food and Drug Administration (FDA) to return cytarabineliposome injection (DepoCyt) to the market. Liposomal cytarabineis the only FDA-approved treatment for patients with lymphomatous meningitis.
Chiron, which holds the US marketing rights, and SkyePharmavoluntarily withdrew liposomal cytarabine from the market in October 1999 when,upon routine stability testing, it was discovered that certain batches did notmeet all regulatory specifications. There were no adverse events attributed tothe recalled batches.
"We are delighted to bring this most important product backto the market," said Michael Ashton, chief executive officer of SkyePharma."Manufacturing issues have been resolved by a combined effort with ourpartner, Chiron, truly highlighting the value of this joint venture between ourtwo companies."
Multicenter Trial Results
A controlled, open-label, multicenter study showed thattreatment with liposomal cytarabine produced a 41% response rate (vs 6% withstandard cytarabine) in patients with lymphomatous meningitis. Patients wereconsidered responders when no cancer cells remained in the cerebrospinal fluidand there was no progression of neurologic symptoms.
As expected with standard intrathecal chemotherapy, the mostdocumented side effect was arachnoiditis, an inflammation of the covering of thebrain and spinal cord that causes symptoms such as headache, nausea, vomiting,and fever. This side effect was generally transient and reversible and did notlead to missed treatments. Patients receiving liposomal cytarabine should betreated concurrently with dexamethasone to reduce the incidence and severity ofarachnoiditis.
The drug is an injectable, sustained-release formulation of thechemotherapeutic agent cytarabine. Using a proprietary lipid-based drug deliverytechnology, it gradually releases cytarabine into the cerebrospinal fluid andextends the dosing interval to once every 2 weeks, as compared to the standardintrathecal chemotherapy dosing of two times per week.
"By providing continuous delivery of cytarabine over a 2week period, DepoCyt offers patients the advantages of fewer injections and lessfrequent hospital visits," said Maurice Wolin, MD, vice president ofoncology development for Chiron. "We are pleased to be making thisimportant treatment available to patients in need."