Pfizer and Astellas Pharma announced that the US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for XTANDI (enzalutamide).

XTANDI is an androgen receptor inhibitor designed to treat patients with castration-resistant prostate cancer (CRPC) and metastatic castration-sensitive prostate cancer (mCSPC).

mCSPC is a type of prostate cancer that spreads to other parts of the body and responds to a medical or surgical treatment that lowers testosterone.

Pfizer and Astellas have signed an agreement in October 2009, to jointly develop and commercialise enzalutamide.

Pfizer Oncology global president Andy Schmeltz said: “Today’s approval adds to over a decade of global clinical research aimed at better understanding the potential benefit of XTANDI for men with advanced prostate cancer.

“The FDA approval marks continued progress to help meet the needs of patients, including men living with metastatic castration-sensitive prostate cancer.”

The FDA approval of XTANDI is based on the results from ARCHES trial

XTANDI is the first and only FDA approved oral treatment of advanced prostate cancers, including non-metastatic and metastatic CRPC and mCSPC.

The FDA approval is supported by the results from ARCHES, a randomized Phase 3 clinical study that enrolled 1,150 men with mCSPC. The clinical study has reached its primary endpoint of radiographic progression-free survival (rPFS).

The ARCHES study data showed that XTANDI, in combination with androgen deprivation therapy (ADT) has reduced the risk of radiographic progression or death, compared to placebo plus ADT.

The study reported safety analysis, which is generally consistent with the safety profile of the drug in previous clinical trials in CRPC. The common adverse reactions included hot flush, asthenic conditions, hypertension, fractures, and musculoskeletal pain.

Astellas senior vice president and oncology therapeutic area head Andrew Krivoshik said: “XTANDI has been established as a standard of care for men with castration-resistant prostate cancer and has been prescribed to more than 420,000 patients worldwide since it was first approved in 2012.

“This approval in metastatic castration-sensitive prostate cancer means physicians can now offer XTANDI to men earlier in their advanced prostate cancer treatment journey.”