SkyePharma PLC and Chiron Corporation have received clearance from the US Food and Drug Administration (FDA) to return cytarabine(Drug information on cytarabine) liposome injection (DepoCyt) to the market. Liposomal cytarabine is the only FDA-approved treatment for patients with lymphomatous meningitis.
Chiron, which holds the US marketing rights, and SkyePharma voluntarily withdrew liposomal cytarabine from the market in October 1999 when, upon routine stability testing, it was discovered that certain batches did not meet all regulatory specifications. There were no adverse events attributed to the recalled batches.
"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."
Multicenter Trial Results
A controlled, open-label, multicenter study showed that treatment with liposomal cytarabine produced a 41% response rate (vs 6% with standard cytarabine) in patients with lymphomatous meningitis. Patients were considered responders when no cancer cells remained in the cerebrospinal fluid and there was no progression of neurologic symptoms.
As expected with standard intrathecal chemotherapy, the most documented side effect 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 liposomal cytarabine should be treated concurrently with dexamethasone(Drug information on dexamethasone) to reduce the incidence and severity of arachnoiditis.
The drug is an injectable, sustained-release formulation of the chemotherapeutic agent cytarabine. Using a proprietary lipid-based drug delivery technology, it gradually releases cytarabine into the cerebrospinal fluid and extends the dosing interval to once every 2 weeks, as compared to the standard intrathecal chemotherapy dosing of two times per week.
"By providing continuous delivery of cytarabine over a 2 week period, DepoCyt offers patients the advantages of fewer injections and less frequent hospital visits," said Maurice Wolin, MD, vice president of oncology development for Chiron. "We are pleased to be making this important treatment available to patients in need."