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).
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.
Read more: https://www.pharmaceutical-technology.com/news/pfizers-snda-xtandi-gets-priority-review-prostate-cancer/
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.
Read more: https://www.pharmaceutical-technology.com/news/pfizers-snda-xtandi-gets-priority-review-prostate-cancer/