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NICE recommends Accord’s oral hormone therapy Orgovyx for advanced prostate cancer

The drug is now the first oral treatment of its kind to be approved by the agency
- PMLiVE

The National Institute for Health and Care Excellence (NICE) has recommended Accord’s oral hormone therapy, Orgovyx (relugolix), for use in advanced prostate cancer patients.

The androgen deprivation therapy (ADT), which has been specifically recommended for those with hormone-sensitive cases of the disease, is now the first oral treatment of its kind to be approved by the agency.

Prostate cancer is the most common cancer in men in the UK, with approximately 51,000 new cases diagnosed in England in 2022 alone.

ADTs work by reducing the level of androgen hormones, such as testosterone, which are needed by prostate cancer cells to grow.

Orgovyx reduces levels of testosterone by blocking the production of the hormone in the testes and is taken as a tablet, offering an alternative to other hormone treatments given by injection and providing patients with the option to take it at home.

NICE’s final draft guidance on the drug was supported by clinical trial evidence suggesting that Orgovyx is better at reducing testosterone to levels that stop cancer growth in the longer term than leuprolide and reduces the risk of serious cardiovascular events compared to leuprolide.

An indirect treatment comparison also demonstrated that Orgovyx works as well as other ADTs, the agency outlined.

Helen Knight, director of medicines evaluation at NICE, said: “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.”

The recommendation comes just one month after a mid-stage trial led by researchers from the Royal Marsden NHS Foundation Trust and the Institute of Cancer Research found that hormone therapy in combination with radiotherapy could delay the need for chemotherapy in advanced prostate cancer patients.

Findings from the national TRAP study demonstrated that, instead of disease progression after hormone therapy indicating that the cancer has become resistant to treatment, it may just be that some tumours are resistant. The team noted that if the tumours are treated with radiotherapy, the rest of the cancer will still respond to hormone therapy.

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