NICE Approves First Oral Prostate Cancer ADT

The UK's National Institute for Health and Care Excellence (NICE) has issued final guidance recommending Orgovyx (relugolix) as an oral androgen deprivation therapy (ADT) for hormone-sensitive prostate cancer in England. This decision follows draft guidance released last month and introduces an alternative to injectable ADTs for the first time.

Orgovyx, an oral GnRH antagonist, is marketed by Accord Healthcare in Europe through an agreement with Sumitomo Pharma, while Pfizer co-markets the drug with Sumitomo in the United States. According to NICE's recommendation, Orgovyx is now approved for treating prostate cancer in adults with advanced hormone-sensitive disease. The treatment can be used alongside radiotherapy for high-risk, localized, or locally advanced disease. It is also approved as a neoadjuvant treatment before radiotherapy for high-risk localized or locally advanced disease.

Orgovyx received approval in Europe in 2022 based on the results of the Phase III HERO trial. This trial compared the daily oral administration of Orgovyx to leuprolide, a synthetic ADT given by depot subcutaneous or intramuscular injection every three months. The results demonstrated that 96.7% of men who received Orgovyx maintained castration from day 29 through 48 weeks, compared to 88.8% for those who received leuprolide. Additionally, the study revealed a lower incidence of major adverse cardiovascular events in those treated with Orgovyx (2.9%) versus the leuprolide group (6.2%).

Paul Tredwell, executive vice president at Accord for the EMENA region, remarked, "The publication of NICE's final guidance is a hugely positive step for patients living with prostate cancer in England… We are pleased to provide an additional treatment choice to the clinical community and those eligible men living with prostate cancer."