New indication for Astellas/Medivation's Xtandi from US FDA

11 September 2014

The US Food and Drug Administration has approved a new indication for the use of Japanese drug major Astellas Pharma (TYO: 4503) and Medivation’s (Nasdaq: MDVN) Xtandi (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer (CRPC).

This new approved use follows a priority review of the supplemental New Drug Application (sNDA) that was based on results of the Phase III PREVAIL trial. The news pushed Medivation’s shares 2.7% higher to $96.89 in after-hours US trading yesterday, while Astellas gained 2.25% to 1,544.5 yen in Japanese afternoon trading today.

The approval of this new indication for Xtandi triggers $90 million in milestone payments to Medivation under its collaboration agreement with Astellas.

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