What is enzalutamide?
This page is about a new hormone therapy drug called enzalutamide. There is information about
Enzalutamide (pronounced en-zal-loo-tah-my-de) is also known by its brand name Xtandi and as MDV3100. It is a new drug that researchers are testing for advanced prostate cancer.
Prostate cancers depend on male hormones in order to grow. The hormones are called androgens and include testosterone.
Enzalutamide is a type of drug called an androgen receptor antagonist. It blocks a number of steps in the process by which male hormones signal to the cancer cell to grow. It is a tablet that men take once a day for as long as it is working.
Enzalutamide was licensed in the UK in July 2013. The National Institute for Health and Care (NICE) are looking into whether to recommend it as a treatment within the NHS and are due to make a decision in early 2014. But it is on the cancer drugs fund list in England. So until then you can ask your doctors if it's suitable for you and if they agree, you can have it on the NHS.
In Scotland, the Scottish Medicines Consortium (SMC) have recommended enzalutamide should be available within the NHS for men who have advanced prostate cancer. It is only for men who have had docetaxel chemotherapy and when hormone treatment is no longer working.
You may have enzalutamide as part of a clinical trial.
All new drugs go through a detailed research process. Firstly, research in the laboratory finds out if a potential new drug harms cancer cells in any way. Then researchers look at whether it is safe to give to people, what the dose should be, and which side effects it causes.
An international phase 3 trial called AFFIRM tested enzalutamide. It looked at whether it could help men to live longer when they had already had hormone therapy and chemotherapy and their cancer was still growing. The men in the trial either had enzalutamide or a dummy drug (placebo). The results showed that the men who had the dummy tablet lived on average for 1 year. The men who had enzalutamide lived on average for 1½ years.
Researchers are now carrying out a trial called PREVAIL for men with prostate cancer that has spread. It is testing whether enzalutamide helps men who have not had chemotherapy and other types of hormone therapy have stopped working.
In enzalutamide trials so far, the side effects that men had included
- Tiredness (fatigue) – in the AFFIRM trial about 1 in 3 men had fatigue but fewer than 1 in 10 had severe fatigue. Slightly fewer men taking the placebo had fatigue
- Diarrhoea – about 1 in 5 men in the trial had diarrhoea and 1 in 100 had severe diarrhoea, which was slightly more than in the men taking placebo
- Hot flushes – 2 in 10 men taking enzalutamide had hot flushes compared with 1 in 10 taking the placebo
- Pain in joints and muscles – slightly more men taking enzalutamide had joint pain than men taking the placebo (14% compared to 10%)
- An increased risk of infection due to a drop in the number of white blood cells – this affected 15 out of every 100 men (15%)
- Headaches – just over 1 in 10 men (10%) had headaches, which is slightly more than those taking the placebo
- Feeling weak
- Swollen feet and ankles due to fluid build up (known as peripheral oedema)
- Higher blood pressure – this affected around 1 in 20 men taking enzalutamide
In the research some men taking enzalutamide had a seizure (fit). This was rare and affected less than 1 in 100 men (1%). None of the men taking the placebo had a seizure. The researchers recommend that care should be taken in men who may be at higher risk of seizures. This includes men who
- Have a history of seizures
- Have had any kind of brain injury such as a stroke
- Have secondary cancer in the brain
- Are alcoholic
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