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European Union approves Zytiga (abiraterone) for use pre-chemo


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On 15 November 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a new indication for European doctors as follows:

"ZYTIGA is indicated with prednisone or prednisolone for:

the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated".

The CHMP adopted a new contraindication as follows: "Severe hepatic impairment (Child-Pugh Class C)".

Jim Marshall (not a doctor) said ...

Before this decision, in Europe Zytiga (abiraterone) was only recommended after a man had failed chemotherapy with docetaxel (Taxotere).

This decision permits doctors in Europe to prescribe the Zytiga (abiraterone) to men who have failed androgen deprivation therapy (hormone therapy) before they have chemotherapy with docetaxel (Taxotere).

Zytiga (abiraterone) is not recommended if a man has bad liver problems (severe hepatic impairment).

I think this decision is like one by the TGA (Theraputic Goods Administration) in Australia, or the FDA (Food and Drug Administration) in the USA.

That is, it permits doctors to prescribe, but does not cover the payment issue.

... end Jim

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