Orgovyx
Authorised
This medicine is authorised for use in the European Union
relugolix
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Orgovyx is a medicine used to treat advanced cancer of the prostate (a gland of the male reproductive system) in adult patients when the cancer is ‘hormone-sensitive’, which means that it responds to treatments that reduce the levels of testosterone (the male sex hormone).
Orgovyx contains the active substance relugolix.
Orgovyx is available as tablets. The recommended dose is three tablets on the first day of treatment and then one tablet once a day taken around the same time each day.
The medicine can only be obtained with a prescription. For more information about using Orgovyx, see the package leaflet or contact your doctor or pharmacist.
The testicles produce testosterone which can make prostate cancer cells grow. The active substance in Orgovyx, relugolix, works by blocking a step in the process that signals the testicles to produce testosterone.
This step involves the release of a hormone called gonadotrophin-releasing hormone (GnRH) from the brain. By blocking the effects of GnRH, Orgovyx reduces the amount of testosterone in the body and slows down the growth of the prostate cancer cells.
A main study involving 934 men with advanced hormone-sensitive prostate cancer showed that Orgovyx is effective at reducing the amount of testosterone to levels seen in men whose testicles have been surgically removed.
During the first year, 97% of the patients receiving Orgovyx had the required reduction of testosterone levels, compared with 89% of patients receiving leuprorelin (another medicine for prostate cancer). These results showed that Orgovyx was as effective as leuprorelin.
The most common side effects with Orgovyx (which may affect more than 1 in 5 people) are hot flushes, muscle and joint pain and tiredness. Other very common side effects are diarrhoea and constipation.
For the full list of side effects and restrictions for Orgovyx, see the package leaflet.
The European Medicines Agency decided that Orgovyx’s benefits are greater than its risks and it can be authorised for use in the EU.
A main study showed that Orgovyx was as effective as standard treatment with another medicine (leuprorelin) in reducing testosterone levels of patients with advanced hormone-sensitive prostate cancer. Orgovyx was generally well-tolerated by most of the patients. Its side effects were mild and manageable.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Orgovyx have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Orgovyx are continuously monitored. Suspected side effects reported with Orgovyx are carefully evaluated and any necessary action taken to protect patients.
Orgovyx received a marketing authorisation valid throughout the EU on 29 April 2022.
Product information
Latest procedure affecting product information:
PSUSA/00010994/202401
18/11/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Orgovyx
- Active substance
- relugolix
- International non-proprietary name (INN) or common name
- relugolix
- Therapeutic area (MeSH)
- Prostatic Neoplasms
- Anatomical therapeutic chemical (ATC) code
- L02BX
Pharmacotherapeutic group
Endocrine therapyTherapeutic indication
Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer.
News on Orgovyx
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