View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
  1. News
March 20, 2018

Pfizer’s sNDA for Xtandi gets priority review for prostate cancer

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).

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.”

“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.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. A weekly roundup of the latest news and analysis, sent every Friday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU