December 18, 2020

The U.S. FDA has approved Orgovyx™ (relugolix), manufactured by Myovant Sciences, as the first oral hormone therapy indicated to treat advanced prostate cancer in adults.

Prostate cancer is a common form of cancer and is often highly treatable if caught early. Advanced prostate cancer, in which the cancer has spread beyond the prostate gland, is more challenging to treat. One option is to use hormone therapy aimed at reducing the level of male hormones, including testosterone, that play a role in prostate cancer’s spread. Using medication to lower testosterone levels is sometimes referred to as medical castration.

In a clinical study, Orgovyx was 96.7% effective in maintaining castrate levels of testosterone in patients who had advanced prostate cancer. Recommended dosing is 360mg taken by mouth on the first day, then 120mg taken by mouth each day thereafter, at approximately the same time each day. Dosage modification may be required based on other medications the patient may be taking.

Launch and pricing information are not yet available.

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