The GnRH receptor antagonist was approved by the FDA in December 2020 for the treatment of patients with advanced prostate cancer.
The independent specialty pharmacy Biologics by McKesson was designated as a provider of the prostate cancer drug relugolix (Orgovyx).1
Earlier this month, Myovant Sciences, the developer of relugolix, officially launched the GnRH receptor antagonist in the United States, making it available through authorized specialty distributors.
The FDA approved relugolix in December 2020 for the treatment of patients with advanced prostate cancer. The approval was based on data from the phase 3 HERO study, which showed that 96.7% of patients randomized to relugolix maintained castration through 48 weeks, compared with 88.8% of patients receiving leuprolide (P <.001).2
“We are pleased to provide this new prostate cancer therapy with demonstrated robust efficacy and safety, all in one daily pill,” Ashleigh Burdette, senior director of Clinical Innovation at Biologics, stated in a press release. “The COVID-19 pandemic has highlighted the importance of oral treatments for patients, especially those who may experience difficulties and risks associated with traveling to receive treatments.”
The open-label international phase 3 HERO trial included 930 patients treated at 155 clinical sites. The median patient age was 71 years (range, 47-97), with 28.6% of patients being aged ≥75 years. Overall, 31.7% of patients had metastatic disease, 15.5% of patients had a Gleason score of 5-6, 38.6% of patients had a Gleason score of 7, and 43.1% of patients had a Gleason score of 8-10. Half (50.2%) of patients had evidence of biochemical or clinical relapse after local primary intervention with curative intent.
The median PSA level at baseline was 10.8 ng/ml and the average testosterone level at baseline was 427.5 ± 156.2 ng/ml. The ECOG performance status was 0 in 88.1% of patients, 11.9% of patients, had prior androgen-deprivation therapy, and 30.3% had prior radiotherapy.
Patients were randomized in a 2:1 ratio to relugolix at 120 mg orally once daily or leuprolide injections every 3 months. Treatment was administered for 48 weeks, with a primary end point of sustained testosterone suppression to castrate levels (<50 ng/dL) through 48 weeks.
On day 4 of treatment, 56% of the relugolix cohort had castrate levels of testosterone versus 0% of the leuprolide group. On day 15, the rates were 98.7% versus 12%, respectively. Also on day 15, 79.4% of the relugolix arm had a confirmed PSA response, compared with 19.8% of patients on the leuprolide arm (P <.001).
Relugolix was associated with a 54% lower risk of major adverse cardiovascular events compared with leuprolide (HR, 0.46). Major adverse cardiovascular events occurred in 2.9% of the relugolix arm compared with 6.2% of the leuprolide cohort. The study defined major adverse cardiovascular events as nonfatal stroke or myocardial infarction, or death due to any cause.
In the press release, Biologics noted that physicians can submit prescriptions for relugolix pharmacy via phone, fax, or electronic prescription.
1. Shore ND, Saad F, Cookson MS, et al. Oral relugolix for androgen-deprivation therapy in advanced prostate cancer. N Engl J Med. 2020;382(23):2187-2196. doi: 10.1056/NEJMoa2004325
2. ORGOVYX (relugolix), the First FDA-Approved Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer, Available at Biologics by McKesson. Published online January 21, 2021. Accessed January 21, 2021. https://bit.ly/2Y2LD2A.