Partners Pfizer (NYSE: PFE) and Astellas Pharma (TSE: 4503) last week received indication extension approval from the US Food and Drug Administration (FDA) for their androgen receptor signaling inhibitor Xtandi (enzalutamide). The drug is now approved as a treatment for non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). This authorization follows positive results from a Phase III study that demonstrated an improvement in metastasis-free survival (MFS) compared to placebo.
Global Regulatory Submissions for Xtandi Based on Phase III Data
The positive data from the Phase III study have also been submitted to other regulatory agencies worldwide for the same indication, marking a significant step towards expanding the treatment’s availability for patients globally.- Flcube.com
