Pfizer and Astellas Pharma have obtained priority review status from the US Food and Drug Administration (FDA) for the supplemental new drug application (sNDA) of Xtandi (enzalutamide) to treat patients with non-metastatic castration-resistant prostate cancer (CRPC).
Xtandi is an inhibitor of androgen receptor and received FDA approval in 2012 for metastatic CRPC patients who were previously treated with docetaxel. In 2014 it was expanded to include patients with metastatic CRPC.
Patients with non-metastatic CRPC lack clinically detectable evidence of the cancer spreading, apart from a rapid increase in their prostate-specific antigen (PSA) levels. The majority of patients go on to develop metastatic CRPC.
Pfizer oncology chief development officer Mace Rothenberg said: “Treatment options have been limited for men with non-metastatic CRPC, in whom the only evidence of progressive disease is a rapidly rising PSA.
“Xtandi is already established as a standard of care for men with metastatic CRPC. This milestone marks an important step toward our ability to bring Xtandi to CRPC patients in an earlier setting.”
The FDA decision is based on the results of a Phase III trial conducted in 1,401 non-metastatic CRPC patients to compare the combination of Xtandi and androgen deprivation therapy (ADT) with ADT alone.
The primary endpoint of the trial had been met as the risk of metastasis or death was significantly decreased with the combination treatment when compared to the monotherapy.
The European Medicines Agency (EMA) has validated the type II variation submitted for Xtandi seeking to expand the current indication to the same patient population and has started the review process.