A couple of weeks after its approval, Orgovyx (relugolix) is now commercially available in the U.S. for adults with advanced prostate cancer through authorized specialty distributors, the therapy’s developer, Myovant Sciences, has announced.
“Myovant has been focused on ensuring access to Orgovyx for men with advanced prostate cancer as quickly as possible following approval, and we are delighted to announce that it is now available,” David Marek, company CEO, said in a press release.
Orgovyx is a form of hormone therapy, or androgen deprivation therapy (ADT), that blocks the gonadotropin-releasing hormone (GnRH) receptor, reducing the production of testicular testosterone, which is a major driver of prostate cancer.
It was recently approved to treat advanced prostate cancer based on promising data from the HERO Phase 3 trial (NCT03085095). Orgovyx was found to significantly increase the proportion of patients with sustained reductions in testosterone levels over nearly one year, compared with standard-of-care leuprolide acetate.
With this approval, Orgovyx became the first and only oral GnRH receptor inhibitor to win regulatory approval in the U.S. for this indication.
For those interested in accessing this medication, Myovant has launched the Orgovyx Patient Support Program, which will offer patients 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.
“As part of our commitment to redefine care for women and for men, this is a critical step as we work to bring about a new standard of care for men with advanced prostate cancer,” Marek said.
Myovant is also investigating relugolix for the treatment of uterine fibroids (noncancerous growths in the uterus) and endometriosis (a condition in which endometrial tissue grows outside the uterus) in women, in whom the therapy lowers estrogen production.
A combination tablet containing 40 mg relugolix, 1.0 mg estradiol, and 0.5 mg norethindrone acetate is under review by regulatory agencies in the U.S. and Europe for women with uterine fibroids.
Under a recent agreement, Myovant is now collaborating with Pfizer to develop and commercialize relugolix for advanced prostate cancer and for women’s healthcare in the U.S. and Canada. Myovant will receive an upfront payment of $650 million, as well as payments for potential regulatory and sales milestones for a total payment of up to $4.2 billion. Myovant and Pfizer will equally share profits and certain expenses for Orgovyx and the relugolix combination tablet.
“We are excited to join forces with Myovant and combine our capabilities to bring Orgovyx to patients with advanced prostate cancer,” said Andy Schmeltz, global president of Pfizer Oncology. “This strategic collaboration builds on our leadership in serving prostate cancer patients in the U.S. and aligns with our goal to deliver more breakthroughs across the prostate cancer treatment paradigm.”