September 7, 2011
J&J's prostate drug Zytiga gets final nod in Europe
By Tracy Staton
Another new prostate cancer drug will soon hit the market in Europe. Regulators there approved Johnson & Johnson's ($JNJ ) Zytiga pill as a second-line treatment, after a fast-track review. The approval puts Zytiga in competition with Sanofi's Jevtana, also approved as a treatment for patients whose cancer progressed after chemo, in combination with prednisone.
Zytiga's European Medicines Agency nod follows FDA approval in April, and comes on the strength of a study that found Zytiga patients lived an average of 4.6 months longer than placebo patients did, 15.8 months compared with 11.2 months. One advantage: It's a pill, versus an injectable drug like Jevtana--or like Dendreon's Provenge, which could hit the European market in 2013.
"The efficacy, safety and ease of use of abiraterone acetate, a medicine that can be taken at home, will address an important unmet medical need for many patients, helping them to live longer with a better quality of life and less pain," Institut Gustave Roussy's Karim Fizazi, an investigator in the late-stage trial, said in a statement.
As Dow Jones notes, the worldwide market for prostate cancer drugs now stands at around $1 billion, but is expected to grow to $5 billion by 2015 as new, expensive treatments are introduced. Jevtana runs $35,000 in the U.K. and some $48,000 in the U.S., while Provenge is now priced at $93,000 in the States. Zytiga's U.S. price is $5,000 per month, or $40,000 for an 8-month course. Decision Resources has predicted $910 million in peak sales for the J&J drug.
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