Zytiga extended in EU

pharmafile | January 15, 2013 | News story | Sales and Marketing |  EU, J&J, JJ, Janssen, Zytiga 

Janssen is celebrating the European Commission’s decision to extend the licence for its prostate cancer treatment Zytiga.

The once-daily pill can now be used to treat metastatic castration-resistant prostate cancer (mCRPC) before chemotherapy.

Until now Zytiga (abiraterone acetate) with prednisone and prednisolone has only been approved for mCRPC patients whose disease has progressed on or after docetaxel-based chemotherapy.

Zytiga can now be used in that combination in men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy – but for whom chemotherapy has not been indicated.

The drug interferes with the production of androgen, which fuels prostate cancer growth, by inhibiting the CYP17 enzyme complex in the testes, adrenals and the tumour itself. 

For Janssen the advantage of the new decision is that patients may now be receiving its brand earlier in the treatment pathway, thus increasing sales. Analysts have previously suggested that Zytiga could reach peak annual sales of $2.5 billion and take more market share.

The CHMP recommended the drug in this broader indication after looking at data from the Phase III COU-AA-302 study, which showed a radiographic progression-free survival benefit and a strong trend in overall survival.

Jane Griffiths, company group chairman for Janssen EMEA, said: “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.”

The drug is already well-thought of by health authorities because of its effectiveness. Despite Zytiga’s high price tag of $5,000 per month NICE has recommended it on the NHS – although Janssen had to offer an undisclosed price cut.

In 2008, there were 370,000 new cases of prostate cancer diagnosed in Europe, with nearly 90,000 men dying from the disease.

Adam Hill