Janssen’s prostate cancer drug gains European backing
pharmafile | July 26, 2011 | News story | Sales and Marketing |Â Â Zytiga, prostate cancerÂ
Janssen’s prostate cancer treatment Zytiga has been recommended by Europe’s CHMP, paving the way for possible third quarter launch.
The CHMP recommended Zytiga (abiraterone acetate), in combination with prednisone, to treat metastatic castration resistant prostate cancer in men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
The drug was reviewed under an accelerated timetable because of the poor prognosis of the target patient population, which represents a high, unmet medical need.
The panel said Zytiga’s novel mechanism of action has the potential to offer ‘an alternative therapeutic option’ for these prostate cancer patients.
The advice will now be considered by European regulator the EMA, which usually takes around three months to confirm the CHMP’s recommendations.
The UK’s cost effectiveness body NICE is already gearing up to assess the drug.
The clinical evidence it will consider includes a pivotal phase III trial that showed Zytiga, in combination with prednisone, resulted in a 35% reduction in the risk of death (14.8 months vs. 10.9 months), and a 3.9 month difference in median survival compared to placebo plus prednisone.
In the US the FDA approved the drug in May this year and analysts have said peak annual sales could reach $800 to $1 billion.
But it will not have the market to itself – Sanofi’s chemotherapy drug Jevtana (cabazitaxel) has already received both US and EU approval within the past year.
J&J’s Zytiga may have an edge, despite coming to market later, because as an oral treatment it will be easier for patients to take.
Ben Adams
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