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Enzalutamide in prostate cancer: Hints of added benefit
Date:12/6/2013

Enzalutamide (trade name: Xtandi) has been approved since June 2013 for men with metastatic prostate cancer in whom the commonly used hormone blockade is no longer effective and who have already been treated with the cytostatic drug docetaxel. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether this new drug offers an added benefit over the appropriate comparator therapy specified by the Federal Joint Committee (G-BA).

In comparison with "best supportive care", there is a hint of a major added benefit in patients whose internal organs are free of metastases of the tumour. In patients with such visceral metastases, the extent of added benefit is "considerable".

"Best supportive care" was appropriate comparator therapy

The G-BA specified "best supportive care" (BSC) as appropriate comparator therapy. BSC means a therapy that provides the patient with the best possible individually optimized supportive treatment to alleviate symptoms (e.g. adequate pain therapy) and improve quality of life.

Adequate pain therapy questionable in approval study

Studies that tested a comparison of enzalutamide with or without BSC versus BSC alone could be considered for the benefit assessment. The approval study (AFFIRM) met these criteria. It was unclear, however, whether patients in the control group actually received adequate pain therapy throughout the entire study and whether therefore the criteria of BSC were fulfilled. Due to this increased uncertainty, at most "hints", but not "indications" could be derived from the AFFIRM results.

Survival advantage only in patients without tumours in internal organs

As the data showed, patients in the enzalutamide arm of the study survived longer than in the control group. However, there were also indications th
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Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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