FDA grants approval for Xtandi in metastatic prostate cancer

1 October 2014

Japanese drug major Astellas Pharma (TYO: 4503) and Medivation (Nasdaq: MDVN) has received expanded approval for Xtandi (enzalutamide) from the US Food and Drug Administration for the treatment of metastatic castration-resistant prostate cancer.

The new indication that has been approved allows for the use of Xtandi in patients who are chemotherapy-naive.

Xtandi, an oral, once-daily androgen receptor inhibitor capsule, has been approved for the indication based on the results of a Phase III clinical trial which showed a statistically-significant improvement in overall survival and delayed time to radiographic progression or death compared to placebo and testosterone-lowering treatment. It was also shown to increase the amount of time before initiation of chemotherapy was deemed necessary.

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