Once again, there is a new treatment for men with advanced prostate cancer on the horizon. We usually don’t write about unapproved prostate cancer treatments. Still, this one is just around the corner, it is novel, it offers benefits over the current standard of care, and it is perfect for the COVID ERA as well as in regular times.
The current standard of care for men with advanced prostate cancer is hormone therapy or ADT. Currently, all the approved gonadotropin-releasing hormone (GnRH) antagonist or ADT drugs like Lupron are given by injection. Injections require that a man go into the hospital or into the doctor’s office, which requires physical contact between the patient and a member of the medical care team, an activity we want to try and minimize during the COVID-19 pandemic.
Myovant Sciences has developed an alternative gonadotropin-releasing hormone (GnRH) antagonist named relugolix. Their still investigational treatment is an oral (taken by mouth) as opposed to an injectable gonadotropin-releasing hormone (GnRH) antagonist. It has completed a very successful phase III clinical trial called HERO has been submitted to the FDA for approval. We at Cancer ABCs believe relugolix will be approved by the FDA shortly.
In an additional supporting clinical trial published by the New England Journal of Medicine involving men with advanced prostate cancer, relugolix administered orally once a day achieved both a rapid (four days) and sustained suppression of testosterone (96.7 and 88.8 percent of men receiving relugolix or leuprolide, respectively, maintained castration or sustained testosterone suppression to castrate levels through 48 weeks). These levels were superior to the control group using leuprolide (Lupron). Relugolix also had a 54% lower risk of major adverse cardiovascular events than leuprolide and a quicker recovery of testosterone when stopping the treatment.
Overall, it is clear that relugolix has demonstrated superiority over leuprolide (Lupron) for achieving castration, maintaining castration, lower cardio event risks, and faster recovery.
Given relugolix’s significant superiority and its ability to be used without any additional physical contact between a man and their medical team, Cancer ABCs has suggested that the developing company, Myovant, not only apply for FDA approval but also asks the FDA to provide emergency use authorization during the pandemic.
If emergency use authorization can be obtained, not only would the drug become immediately available during the pandemic, the insurance issue over payment parity between injectables and oral drugs might become easier to resolve.
