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Myovant’s Relugolix Won’t Be Stopped By Missed Endpoint

Approval Still Expected And Differentiation Remains Intact

 
• By Mary Jo Laffler

The miss on improving castration resistance-free survival in Phase III trial is not likely to affect the ongoing FDA review, the company and analysts agree.

Additional results from the pivotal Phase III HERO study failed to show an improvement in castration resistance-free survival for Myovant Sciences Ltd.’s oral GnRH candidate relugolix against leuprolide, but the stellar performance on the testosterone suppression primary endpoint and the drug’s advantages on speed and safety are likely enough to support approval and a strong commercial launch.

HERO is the trial supporting the new drug application (NDA), which is under priority review with a 20 December action...

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