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 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
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 to reduce the incidence and severity of
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."