Janssen Submits Supplemental New Drug Application for Zytiga to Treat Metastatic Prostate Cancer

Janssen Submits Supplemental New Drug Application for Zytiga to Treat Metastatic Prostate Cancer
Janssen Biotech seeks U.S. approval to use a triple combination treatment with Zytiga (abiraterone acetate), prednisone and androgen deprivation therapy (ADT) for men with high-risk metastatic hormone naïve prostate cancer (HNPC) or newly diagnosed, high-risk metastatic hormone sensitive prostate cancer (HSPC). As such, the Danish pharmaceutical giant submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for that purpose. Metastatic hormone-naïve prostate cancer (mHNPC) is prostate cancer that has spread to other locations in the body but has not been previously treated with ADT, and is not castration- resistant. Metastatic hormone-sensitive prostate cancer (mHSPC) is prostate cancer that still responds to testosterone suppression therapy. The application follows promising results from the LATITUDE Phase 3 trial (NCT01715285), testing the triple combo for newly diagnosed, high-risk metastatic prostate cancer. Researchers outlined the trial's results during the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The study also appeared in the New England Journal of Medicine.  Additional data from the stu
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