EMA Validates Type II Variation For Astellas' XTANDI For Treatment Of Prostate Cancer

(RTTNews) - Astellas Pharma Inc. (ALPMY, ALPMY) said that the European Medicines Agency (EMA) has validated its Type II variation for XTANDI (enzalutamide) for the treatment of patients with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence (BCR) who are unsuitable for salvage-radiotherapy.

The submission to the EMA was based on results from Phase 3 EMBARK trial, which showed XTANDI plus leuprolide reduced risk of metastasis or death by 58%.

According to the company, the EMBARK data are being discussed with other regulatory authorities around the world, including the U.S. Food and Drug Administration (FDA), to support additional license applications for XTANDI in this indication in 2023 and beyond.

Astellas said it has already reflected the impact from the acceptance in its financial forecast of the current fiscal year ending March 31, 2024.

For More Such Health News, visit rttnews.com