NICE Endorses Accord’s Orgovyx for Advanced Prostate Cancer

The National Institute for Health and Care Excellence (NICE) has endorsed Accord's oral hormone therapy, Orgovyx (relugolix), for patients with advanced prostate cancer. This androgen deprivation therapy (ADT) is specifically recommended for men with hormone-sensitive prostate cancer and marks the first oral treatment of its kind to receive such approval from the agency.

Prostate cancer is the most prevalent cancer among men in the UK, with around 51,000 new diagnoses in England in 2022 alone. ADTs function by lowering levels of androgen hormones like testosterone, which are essential for the growth of prostate cancer cells. Orgovyx operates by inhibiting the production of testosterone in the testes. Administered as a tablet, it serves as an alternative to hormone treatments delivered via injection, providing the convenience of home administration.

NICE’s final guidance on Orgovyx is underpinned by clinical trial data indicating that the drug is more effective than leuprolide at reducing testosterone to levels that inhibit cancer growth over the long term. Additionally, Orgovyx is associated with a lower risk of serious cardiovascular events compared to leuprolide. An indirect treatment comparison further showed that Orgovyx is as effective as other ADTs.

Helen Knight, director of medicines evaluation at NICE, stated: “We are continuing to focus on what matters most to people by recommending this innovative and effective treatment that can make a positive difference to people with advanced prostate cancer. [Orgovyx] provides a convenient and flexible treatment option compared with therapies that need to be injected, helping people to avoid travel and time off work and the evidence shows it can improve people’s quality of life.”

This recommendation follows closely on the heels of a mid-stage trial led by researchers from the Royal Marsden NHS Foundation Trust and the Institute of Cancer Research. This trial found that combining hormone therapy with radiotherapy could postpone the need for chemotherapy in patients with advanced prostate cancer.

The national TRAP study revealed that instead of interpreting disease progression after hormone therapy as a sign of treatment-resistant cancer, it might indicate that only certain tumors are resistant. The research team observed that treating these resistant tumors with radiotherapy allows the rest of the cancer to continue responding to ongoing hormone therapy.