In an early benefit assessment under the Act on the German Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether Xtandi (enzalutamide), from USA-based Medivation (Nasdaq: MDVN) and Japanese drug major Astellas Pharma (TYO: 4503) 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," the IQWiG noted.
Xtandi has been approved in Europe 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.
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