The Danish pharmaceutical company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA.) Click here to read the original published article.
The application requests approval to use Zytiga in combination with prednisone and androgen deprivation therapy (ADT) for men with high-risk metastatic prostate cancer that are either hormone naïve or hormone sensitive. Metastatic hormone-naïve means prostate cancer that has spread distantly beyond the prostate gland but has not been previously treated with ADT. Metastatic hormone-sensitive means prostate cancer that has spread beyond the prostate gland that still responds to testosterone suppression therapy. Researchers found that the triple combo of Zytiga, prednisone, and ADT reduced patients’ risk of death by 38% and disease progression fell by 53%. The study also showed that disease progression was delayed by a median of 33 months, when compared to 14.8 months for those in the placebo arm. The prospect of providing another therapeutic option for newly diagnosed, high-risk metastatic prostate cancer is very exciting.