NEW BRUNSWICK, N.J. (AP) -- The European Commission has approved use of Johnson & Johnson's prostate cancer drug earlier in treatment, making it available for more men, the company said Friday.
Zytiga, known chemically as abiraterone, can now be given to men with advanced prostate cancer that hasn't responded to hormonal treatment and who have not yet had chemotherapy. Until now, the once-a-day pill was only approved in European Union countries for use in men whose prostate cancer had worsened during or after chemotherapy.
The new approval was based on a review by EU health advisers of a new late-stage study of 1,088 men showing Zytiga increased survival without progression of the cancer and delayed the need for chemotherapy, according to Johnson & Johnson, which is based in New Brunswick, N.J.
Jane Griffiths, J&J's chairman for its Janssen unit in Europe, the Middle-East and Africa, said in a statement that the new approval "will help fill a critical medical need."
"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," she said.
Zytiga, first approved in 2011, is on sale in more than 60 countries, including the U.S.
Cancer of the prostate, the gland surrounding the urethra that produces part of the seminal fluid, can progress so slowly that treatment isn't needed, or it can grow and spread to other body parts very quickly, depending on the individual patient and characteristics of his tumor.
Each year, prostate cancer kills roughly 90,000 men in Europe and about 28,000 in the U.S.
Shares of Johnson & Johnson rose 20 cents to $72.39 in afternoon trading Friday. They are near the high end of their 52-week range of $61.71 to $72.74.
- Disease & Medical Conditions
- prostate cancer
- European Union countries
- The European Commission