The approval, granted under priority review, was based on data from the HERO Phase 3 trial (NCT03085095), in which Orgovyx significantly increased the proportion of patients with sustained reductions in testosterone levels over nearly one year, compared with standard-of-care leuprolide acetate.
Treatment also lowered the risk of major cardiovascular events by more than half.
With this decision, Orgovyx is now the first and only oral gonadotrophin-releasing hormone (GnRH) receptor inhibitor to win regulatory approval in the U.S. for this indication. According to Myovant, Orgovyx is expected to be commercially available in January.
“With the approval of Orgovyx, men with advanced prostate cancer now have a new oral treatment option that has demonstrated robust efficacy and safety, all with one pill taken once-a-day,” Lynn Seely, MD, CEO of Myovant Sciences, said in a press release.
To help those prescribed Orgovyx, Myovant is launching the Orgovyx Patient Support Program. Through that program, patients will have access to a free trial of the therapy for up to two months, help with verification of insurance plans, copay support for commercially insured patients, and assistance for uninsured patients.
More information on the program is available by calling the 833-674-6899 Monday through Friday, 8 a.m. to 8 p.m. ET.
“We are incredibly grateful to the men and investigators who participated in the HERO study and to the FDA for expediting the review and approval of Orgovyx through its Priority Review pathway,” Seely added.
Orgovyx is a small molecule inhibitor of the GnRH receptor in the brain, to lower the production of testosterone, a major driver of prostate cancer. The molecule is a form of hormone therapy, or androgen deprivation therapy (ADT), a mainstay for prostate cancer treatment.
The HERO trial compared Orgovyx to leuprolide acetate, the current standard-of-care ADT therapy, in approximately 1,100 men with advanced prostate cancer. The trial is still recruiting men, ages 18 and older, at locations in China.
Its main goal was to determine the proportion of men who achieved a sustained reduction in testosterone — to castrate levels, defined as less than 50 ng/dL — from week five through week 48.
Secondary measures included reductions in the levels of prostate-specific antigen (PSA), a cancer biomarker; the proportion of patients achieving a profound castration; and the time patients lived without acquiring resistance to ADT treatment.
Overall, data showed that significantly more patients on Orgovyx achieved sustained castration over the 48 weeks (96.7%), than those on leuprolide acetate (88.8%).
Orgovyx was also much faster at lowering testosterone to castration levels — 98.7% of patients reached castrate levels after 15 days, versus 12.1% of those given leuprolide acetate — and increased the proportion of patients with a 50% reduction in their PSA levels (79.4% vs. 19.8%) after five weeks.
In a subset of 150 patients who discontinued treatment as part of the trial, men on Orgovyx saw their testosterone levels return to normal much faster (within 90 days) than those on leuprolide acetate.
Notably, men treated with Orgovyx had a 54% lower risk of serious cardiovascular adverse events.
“I am enormously pleased by the approval of Orgovyx and believe it has the potential to usher in a new standard of care for men with prostate cancer requiring androgen deprivation therapy,” said Neal Shore, MD, medical director of the Carolina Urologic Research Center and a member of the HERO program steering committee.
“For the first time, we now have a once-daily oral treatment that effectively and rapidly suppresses testosterone, with a safety analysis showing a lower incidence of major adverse cardiovascular events compared to leuprolide injections … as evaluated in the Phase 3 HERO study,” he added.
An updated trial analysis of the trial, however, showed that Orgovyx failed to significantly extend the time patients lived without acquiring resistance to testosterone-lowering medications.
“Prostate cancer is a very personal journey, but a universal truth is that those of us living with this disease want better treatments and options. That is why the approval of Orgovyx is such an exciting milestone that brings a long-awaited oral treatment option to men with advanced prostate cancer,” said Thomas Farrington, president and founder of the Prostate Health Education Network.
“It is so important for men to speak with their doctor and explore what treatment is right for them as they focus on their overall health,” Farrington added.
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