Pfizer and Astellas' XTANDI® Approved by U.S. FDA in Earlier Prostate Cancer Treatment Setting November 16, 2023 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced that the companies received an approval by the U.S. Food and Drug Administration (FDA) of a supplemental New Drug Application for XTANDI® (enzalutamide), following FDA expedited development and review programs (Priority Review designation, Fast Track designation, Real-time Oncology Review), based on results from the Phase 3 EMBARK trial. With this approval, XTANDI becomes the first and only androgen receptor signaling inhibitor approved by the FDA for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). Patients with nmCSPC with high-risk BCR may be treated with XTANDI with or without a gonadotropin-releasing hormone (GnRH) analog therapy.Read the full press release by Pfizer here. Read More About Prostate Cancer Enjoy our library of additional news articles, our Journey to ZERO blog, and our ZEROHour newsletter. ZERO in the News ZERO in the News Read features about ZERO Prostate Cancer in the news—covering events, personal stories, advocacy efforts, and more! ZEROHour ZEROHour ZEROHour features news about prostate cancer, updates on ZERO’s initiatives and activities, and featured stories of those impacted by the disease. Journey to ZERO Journey to ZERO Our Journey to ZERO blog features commentary and discussion about what's happening in the prostate cancer community, stories and inspiration from people impacted by the disease, and insights on news and current events. About Prostate Cancer Clinical Trials Prostate Cancer News More for you
Pfizer and Astellas' XTANDI® Approved by U.S. FDA in Earlier Prostate Cancer Treatment Setting November 16, 2023
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced that the companies received an approval by the U.S. Food and Drug Administration (FDA) of a supplemental New Drug Application for XTANDI® (enzalutamide), following FDA expedited development and review programs (Priority Review designation, Fast Track designation, Real-time Oncology Review), based on results from the Phase 3 EMBARK trial. With this approval, XTANDI becomes the first and only androgen receptor signaling inhibitor approved by the FDA for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). Patients with nmCSPC with high-risk BCR may be treated with XTANDI with or without a gonadotropin-releasing hormone (GnRH) analog therapy.Read the full press release by Pfizer here.
Read More About Prostate Cancer Enjoy our library of additional news articles, our Journey to ZERO blog, and our ZEROHour newsletter. ZERO in the News ZERO in the News Read features about ZERO Prostate Cancer in the news—covering events, personal stories, advocacy efforts, and more! ZEROHour ZEROHour ZEROHour features news about prostate cancer, updates on ZERO’s initiatives and activities, and featured stories of those impacted by the disease. Journey to ZERO Journey to ZERO Our Journey to ZERO blog features commentary and discussion about what's happening in the prostate cancer community, stories and inspiration from people impacted by the disease, and insights on news and current events.
