21 August 2019 - Xtandi supplemental new drug application seeks to add an indication for men with prostate cancer that has spread but is sensitive to hormone therapy.

Astellas Pharma and Pfizer announced today that the U.S. FDA has accepted for review the filing of a supplemental new drug application for Xtandi (enzalutamide) to add an indication for the treatment of men with metastatic hormone-sensitive prostate cancer. The application has also been granted priority review, a designation given to those applications for drugs that, if approved, may offer significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications. 

The submission is based on results from the Phase 3 ARCHES trial presented at the 2019 Genitourinary Cancers Symposium in February and published in The Journal of Clinical Oncology in July 2019.

Read Astellas press release