The Case Against the European Medicines Agency's Change to the Label for Radium-223 for the Treatment of Metastatic Castration-resistant Prostate Cancer

We write regarding a recent label change recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) and implemented by the European Medicines Agency (EMA) for the bone-targeted agent radium-223 (Xofigo).1 

The EMA has concluded its review of the cancer medicine and has recommended restricting its use to patients who have had two previous treatments for metastatic castration-resistant prostate cancer (mCRPC) or who cannot receive other treatments. Depending on how these recommendations are interpreted, they might effectively restrict the use of this agent to the terminal phase of the illness.

We believe that these restrictions are not justified on the basis of the available evidence and could result in fewer patients benefiting from this drug.

References:
1. European Medicines Agency. 2018 September 28 [Epub] EMA/680161/2018. EMA Restricts Use of Prostate Cancer Medicine Xofigo

Joe M. O’Sullivan,1 Daniel Heinrich,2 Nicholas D. James,3 Sten Nilsson,4 Piet Ost,5 Christopher C. Parker,6 Bertrand Tombal7

1. Centre for Cancer Research and Cell Biology, Queen's University, Belfast City Hospital, Belfast, United Kingdom
2. Akershus University Hospital, Lørenskog, Norway
3. University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom
4. Karolinska Hospital, Stockholm, Sweden
5. Ghent University, Ghent, Belgium
6. Institute of Cancer Research, Sutton, United Kingdom
7. Université Catholique de Louvain, Louvain, Belgium

European Association of Urology. 2018, Nov 16 [Epub] O'Sullivan JDTDDIFFDM, et al. The Case Against the European Medicines Agency's Change to the Label for Radium-223 for the Treatment of Metastatic Castration-resistant Prostate Cancer. Eur Urol (2018), https://doi.org/ 10.1016/j.eururo.2018.11.003
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