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Zytiga approved to treat prostate cancer


Zytiga is a medicine that contains the active substance abiraterone acetate. It is available as tablets (250 mg).

 

Zytiga is used to treat cancer of the prostate (a gland of the male reproductive system) in adult men.
It is used when the cancer is metastatic (has spread to other parts of the body) and when castration treatment (stopping the production of male hormones in the body) or docetaxel-based anticancer treatments have not worked or no longer work.
Zytiga is used together with the medicines prednisone or prednisolone.
The medicine can only be obtained with a prescription.
Zytiga tablets are swallowed whole with water at least two hours after eating and at least one hour before further food. The recommended dose is four tablets once per day. If patients develop liver problems, treatment should be interrupted. Treatment may be resumed at a reduced dose if liver function returns to normal, but should be stopped if liver problems continue.
The active substance in Zytiga, abiraterone acetate, stops the body from producing testosterone, a male hormone. Abiraterone does this by blocking an enzyme (a type of protein) called CYP17 found in the testes and elsewhere in the body. Because the cancer needs a supply of testosterone to survive and grow, by stopping the production of testosterone, abiraterone acetate may slow the growth of the prostate cancer.
The effects of Zytiga were first tested in experimental models before being studied in humans.
Zytiga was compared with placebo (a dummy treatment) in one main study involving 1,195 men with prostate cancer whose disease had got worse despite castration treatment or chemotherapy with docetaxel. Patients were treated with prednisone or prednisolone together with either Zytiga or placebo. The main measure of effectiveness was overall survival (how long the patients lived).
Patients treated with Zytiga lived for just under 15 months from the start of treatment, while patients given placebo lived for just under 11 months.
The most common side effects with Zytiga (seen in more than 1 patient in 10) were urinary tract infection, hypokalaemia (low blood potassium levels), hypertension (high blood pressure) and peripheral oedema (swelling of the limbs due to fluid retention). Zytiga must not be used in people who are hypersensitive (allergic) to the active substance or any of the other ingredients. It is not for use in women and must not be given to women who are or who may be pregnant.
The CHMP noted that Zytiga in combination with prednisone or prednisolone improved survival compared with placebo. The Committee noted that there were very few alternative treatments for metastatic prostate cancer which has progressed despite castration treatment or docetaxel-based chemotherapy. The Committee also considered the fact that Zytiga is given by mouth to be a further advantage. It noted that the impact Zytiga may have on the liver is not fully understood, but considered that its main risks were well known and could be managed. Therefore, the CHMP concluded that the benefits of Zytiga were greater than its risks, and recommended it be granted marketing  uthorization.
The European Commission granted a marketing  uthorization valid throughout the European Union for Zytiga on 5 September 2011.
 

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Prepared by: Laila Nour


Source :

 

European Medicine Agency

 






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