FDA approves new indication for J&J prostate cancer drug
SILVER SPRING, Md. — The Food and Drug Administration has approved a new use for a cancer drug made by Johnson & Johnson, the agency said Monday.
The FDA announced the approval of Zytiga (abiraterone acetate), made by J&J subsidiary Janssen Biotech, for men with castration-resistant prostate cancer that has spread to other parts of the body, for use prior to receiving chemotherapy. The drug was already approved for castration-resistant prostate cancer in men who had already undergone chemotherapy treatment.
In castration-resistant prostate cancer, the cancer cells continue to grow even when men have undergone drug treatment or surgery to block testosterone, which stimulates the growth.
"Today's approval demonstrates the benefit of further evaluation a drug in an earlier disease setting and provides patients and healthcare providers the option of using Zytiga earlier in the course of treatment," FDA Office of Oncology Drug Products director Richard Pazdur said.