DepoCyte - withdrawal of application for variation to marketing authorisation
Application withdrawn
The application for a change to this medicine's authorisation has been withdrawn.
cytarabine
Post-authorisationHuman
DepoCyte is a suspension for injection that contains 50 mg of the active substance cytarabine. DepoCyte is used to treat lymphomatous meningitis: this is a condition where lymphoma tumour cells have spread to the membranes that surround the nervous system (meninges). DepoCyte helps control the symptoms of the disease. DepoCyte is injected directly into the nervous system, in the space between the lining of the spinal cord and brain (intrathecal injection).
DepoCyte was to be used in the treatment of solid tumour neoplastic meningitis: this is a disease where cancer cells, originally from a solid tumour (such as lung or breast cancer), spread to the membranes of the nervous system. DepoCyte was to be injected intrathecally.
The active substance in DepoCyte, cytarabine, is an anti-cancer agent. It is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group of anti-metabolites. Cytarabine has been used as an anti-cancer medicine since the 1970s. DepoCyte contains cytarabine in a special formulation: the active substance is contained in liposomes (small fatty particles) from which it is slowly released.
The company presented the results of two studies, involving 164 patients with solid tumour neoplastic meningitis. DepoCyte was compared with methotrexate (another anti-cancer medicine), both medicines being administered intrathecally. The studies measured how long it would take before the disease would progress.
The application was at day 90 when the company withdrew. The evaluation was finished and the CHMP would have given a negative opinion.
The CHMP normally takes up to 90 days to adopt an opinion after it has received an application for a change to a marketing authorisation. Following CHMP opinion, it usually takes around 6 weeks for the European Commission to update the licence.
Based on the review of the data at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that DepoCyte could not be approved for the intrathecal treatment of solid tumour neoplastic meningitis.
The CHMP had concerns that the studies presented by the Company had not sufficiently shown that Depocyte was as effective as, or more effective than intrathecal methotrexate. They had concerns with the way the data were analysed.
Therefore, at the time of the withdrawal, the CHMP's view was that it had not been shown that the benefits of DepoCyte in the treatment of solid tumour neoplastic meningitis were greater that its risks.
The letter from the company notifying the EMEA of the withdrawal of DepoCyte is available under the tab 'All documents'.
The company has informed the CHMP that the decision has no consequences for patients enrolled in clinical trials or compassionate use programmes. If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
There are no consequences for DepoCyte's use in the indications for which it is already authorised, where the known benefit and risk remain unchanged.