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NICE recommends ORGOVYX® (relugolix) as the first oral ADT treatment for hormone sensitive prostate cancer in England
Prostate cancer is the most common cancer in men across the UK with 44,000 new cases diagnosed in England each year and almost ten times as many men living with the condition. Since the early 1990s diagnostic techniques have advanced and prostate cancer incidence rates have increased by more than half (53%) in males in the UK (2017-2019).
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Prostate cancer cells usually require androgen (male) hormones, such as testosterone, to grow. Stopping the release of testosterone from the testicles in prostate cancer is called medical castration and is a cornerstone of the medical treatment of prostate cancer. Injectable ADTs are the standard agents for achieving androgen deprivation for prostate cancer . Relugolix is an oral ADT treatment for hormone-sensitive prostate cancer.
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The NICE decision follows marketing authorisation granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in June 2022 for the treatment of adult patients with advanced hormone sensitive prostate cancer. It further received a license variation for Great Britain in December 2023 to include use in combination with radiotherapy as neoadjuvant or adjuvant treatment in high-risk localised or locally advanced hormone-sensitive prostate cancer.
Relugolix is a gonadotrophin-releasing hormone (GnRH). By binding to the GnRH receptor, GnRH antagonists reduce the production of testicular testosterone, known to stimulate the growth of prostate cancer cells. Relugolix rapidly inhibits pituitary release of luteinizing hormone (LH) and follicle stimulating hormone (FSH) and has been shown to lower testosterone levels.
Relugolix was granted Marketing Authorisation by the MHRA in June 2022 for the treatment of adult patients with advanced prostate cancer who respond to hormone therapy. It further received a license variation for Great Britain in December 2023 to include use in combination with radiotherapy as neoadjuvant or adjuvant treatment in high-risk localised or locally advanced hormone-sensitive prostate cancer.
In the HERO trial, 934 men were randomised 2:1 to daily oral relugolix or leuprolide (leuprorelin), a synthetic ADT given by depot subcutaneous or intramuscular injection every 3 months.
Of men who received relugolix (n= 622), 96.7% (95% confidence interval [CI], 94.9 to 97.9) maintained castration from day 29 through 48 weeks, as compared with 88.8% (95% CI, 84.6 to 91.8) of men receiving leuprolide (n=308). Key secondary end points included cumulative probability of castration of testosterone on day 4 and day 15, profound castrate levels (<20 ng per deciliter) on day 15, and PSA response at day 15 followed by conformation at day 29; all were in favour of relugolix over leuprolide (P<0.001). The overall incidence of adverse events was consistent across treatment groups. Adverse events that occurred in >10% of patients in either group included hot flashes (54.3% vs 51.6%), fatigue (21.5% vs 18.5%), constipation (12.2% vs 9.7%), diarrhoea (12.2% vs 6.8%), arthralgia (12.1% vs 9.1%), and hypertension (7.9% vs 11.7%). Among all the patients, the incidence of major adverse cardiovascular events was 2.9% in the relugolix group and 6.2% in the leuprolide group (hazard ratio, 0.46; 95% CI, 0.24 to 0.88).
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National Institute for Health and Care Excellence. Final Guidance. Available at Overview | Relugolix for treating hormone-sensitive prostate cancer | Guidance | NICE
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View original content:https://www.prnewswire.co.uk/news-releases/nice-recommends-orgovyx-relugolix-as-the-first-oral-adt-treatment-for-hormone-sensitive-prostate-cancer-in-england-302222244.html