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."