EMA raises Concerns regarding Sterility Assurance for DepoCyte and gives Recommendations

A recent inspection conducted jointly by France and the United Kingdom at the Pacira Pharmaceuticals Inc manufacturing site for DepoCyte in San Diego in the United States identified a number of manufacturing deficiencies. These deficiencies are related to a lack on sterility assurance. The available data did not indicate that there is a negative impact on the finished product. But DepoCyte is a prolonged release liposomal suspension for injection containing cytarabine for the intrathecal treatment of lymphomatous meningitis. This means it is administered by injecting it directly into the cerebrospinal fluid. And to prevent potentially harmful effects on the patients, the European Medicines Agency has today agreed on a number of precautionary measures to deal with these manufacturing deficiencies.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended, as a precautionary measure, that DepoCyte be recalled from all European Union countries where suitable alternative treatments are available. For patients already initiated on DepoCyte and for whom alternative treatments are not appropriate, it may be possible for doctors to request a supply of DepoCyte to continue the treatment. In EU countries without suitable therapeutic alternatives, DepoCyte will remain on the market, but with specific recommendations to monitor patients’ safety, in particular for signs and symptoms of infection.

DepoCyte has been authorised in the European Union since 11 July 2001 and is marketed in Austria, Belgium, Bulgaria, the Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom, as well as Iceland and Norway.

For healthcare professionals and doctors with patients treated with DepoCyte a question-and-answer document with detailed recommendations is available on the Agency’s website.

Please also see the complete EMA press release "European Medicines Agency gives recommendations to deal with sterility assurance concerns for DepoCyte" as well as the Q&As on the lack of sterility assurance with DepoCyte (cytarabine). 

Compiled by
Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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