Two new drugs recommended for approval in Europe


Two drugs already approved in the US that either have been or may be used in the treatment of prostate cancer have now been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

Denosumab (Xgeva™) is recommended for the prevention of skeletal-related events (SREs) in adult cancer patients — including in prostate cancer patients who are at risk for SREs as a result of being treated with androgen deprivation therapy.

Ipilimumab (Yervoy™) is recommended for the treatment of  previously unresectable or metastatic melanoma, but ipilimumab is also currently in Phase III clinical trials for the management of metastatic, castration-resistant prostate cancer.

How widely these two drugs will be available in  Europe is still to be assessed. The cost of these drugs is significant in the USA, and European payers will presumably negotiate hard to make sure the cost is seen to be reasonable within the context of nationalized health care systems in the European Union.

2 Responses

  1. What is the status of Yervoy as of July 2013?

  2. Ipilimumab (Yervoy) is approved by the U.S. FDA and by other regulatory agencies around the world exclusively for the treatment of metastatic, unresectable melanoma. It is in clinical trials to see if it may have effects in a variety of other forms of cancer, but to date we are not aware of any data from the various trials designed to investigate the efficacy and safety of ipilimumab in treatment of advanced forms of prostate cancer.

    The estimated date for preliminary release of data from the Phase III randomized, controlled trial of ipilimumab in treatment of metastatic CRPC is still November 2015.

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