Find support groups, events and resources near you

Banner_Prostate Cancer News

Pfizer and Astellas' XTANDI® Approved by U.S. FDA in Earlier Prostate Cancer Treatment Setting

Xtandi brand logo

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.

Share