Friday 11 January 2013

EMA Approves Zytiga Pre Chemo

The European Medicines Agency (EMA) has approved the use of Zytiga before chemotherapy throughout the EU including all member states. This follows shortly after the FDA approval of Zytiga pre chemo.

Just before Christmas the EMA advisory committee on new medications for human use made a recommendation to the EMA to approve Zytiga for use before chemotherapy which has now resulted in its European approval. This means that Zytiga is now available earlier in the key member states of France, Spain, Italy, Germany, Ireland and the UK.

Johnson & Johnson's (JNJ) Janssen-Cilag International announced it has received approval from the European Commission today that allows its cancer treatment Zytiga to be adopted in all of the European Union earlier in the treatment process.

The approved broader indication for this oral medication can now be used in combination with prednisone for the treatment of metastatic castration resistant prostate cancer (mCRPC) in men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy but before chemotherapy.

Until now, Zytiga with prednisone has only been approved to treat men with mCRPC whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

Zytiga was discovered by Prof Gerry Potter in the UK at the ICR research labs of the Royal Marsden Hospital. "This EU approval means that Abiraterone is now approved in the UK for use before chemo. This was the intended design strategy to create a drug that replaces chemotherapy so this is very good news" Prof Potter said. 

Jane Griffiths, company group chairman for Janssen Europe said. "This decision by the European Commission is hugely welcomed news. Treating men with Zytiga before they undergo chemotherapy has been shown to improve outcomes in many patients, both in terms of extending survival and in bettering quality of life."

mCRPC occurs when cancer has spread beyond the prostate to other parts of the body and the disease progresses despite serum testosterone below castrate levels.

According to Janssen, Zytiga is the only approved therapy that inhibits production of androgen, which fuels prostate cancer growth, via inhibiting the CYP17 enzyme complex present at the testes, adrenals and the tumour itself.

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