Pfizer, Astellas' XTANDI Gets FDA Approval For Nonmetastatic Castration-sensitive Prostate Cancer

(RTTNews) - Astellas Pharma Inc. (ALPMY, ALPMY) and Pfizer Inc. (PFE) announced that the FDA approved the supplemental New Drug Application for XTANDI for expanded use for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR).

With this approval, XTANDI becomes the first and only androgen receptor signaling inhibitor approved by the FDA for use with or without a gonadotropin-releasing hormone (GnRH) analog therapy in nonmetastatic castration-sensitive prostate cancer, the company specified.

XTANDI is already approved in the U.S. for the treatment of patients with castration-resistant prostate cancer (CRPC) and metastatic castration-sensitive prostate cancer (mCSPC).

The company stated that the approval is based on results from the Phase 3 EMBARK trial, which evaluated XTANDI plus leuprolide, placebo plus leuprolide, and XTANDI (single agent) in patients with nonmetastatic hormone- (or castration-) sensitive prostate cancer (nmHSPC or nmCSPC) with high-risk BCR.