EMA warns of sterility issues with DepoCyte
pharmafile | August 28, 2012 | News story | Manufacturing and Production |Â Â DepoCyte, Depocyt, Pacira, pharma recallsÂ
The European Medicines Agency has issued a warning to US drugmaker Pacira Pharmaceuticals over manufacturing deficiencies at the plant making its cancer drug DepoCyte.
The agency has also initiated an EU-wide recall of the product, except in cases where no alternative drugs are available to patients treated with DepoCyte (liposomal cytarabine), which is sold as DepoCyt in the US.
An inspection of Pacira’s manufacturing facility in San Diego in July by the regulatory authorities of France and the UK identified a number of manufacturing deficiencies “which could affect the sterility of DepoCyte”, according to an EMA press release.
DepoCyte is approved as a treatment for lymphomatous meningitis, a rare but serious complication of cancer in which malignant cells spread from the primary tumour to the meninges and spinal fluid in the brain.
The EMA has issued a series of recommendations to deal with the sterility issues and protect patients from potential harmful effects whilst still allowing the drug to remain on the market where necessary.
The recall notice applies where alternative treatments – such as non-liposomal cytarabine, methotrexate or thiotepa products suitable for intrathecal administration into the cerebrospinal fluid – are not available, said the agency.
“At present, there is no evidence of any microbial contamination of product on the market or risk to patients”, said the EMA, adding that the recall had been initiated as a “precautionary measure”.
It has also published a question & answer document to help doctors make decisions about treatment of their lymphomatous meningitis patients in light of the recall.
The agency noted that production and batch release of DepoCyte is currently on hold, and new batches of the product will only be manufactured “once all deficiencies have been resolved and a re-inspection has indicated the manufacturing site to be compliant with GMP requirements”.
DepoCyte is Pacira’s biggest product in terms of revenue, accounting for more than $3 million of the firm’s $5.4 million direct product sales in the first six months of 2012.
Phil Taylor
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