BRIEF—sNDA for Xtandi granted priority review

The US Food and Drug Administration (FDA) has granted priority review to a supplemental New Drug Application (sNDA) for Xtandi (enzalutamide) in metastatic hormone-sensitive prostate cancer.

Xtandi, from Japanese drugmaker Astellas and US pharma giant Pfizer, is currently indicated in the USA for the treatment of patients with castration-resistant prostate cancer.

Chris Boshoff, chief development officer, Oncology, Pfizer Global Product Development, said: “The submission is supported by a strong data package, including two Phase III trials investigating Xtandi in men living with this form of prostate cancer.”

The FDA has set a Prescription Drug User Fee Act date for the sNDA in the final quarter of 2019.