Table 1 PRO label claims achieved in the US compared to the EU
Product (brand name/generic name) | US approval year | US product label claim(s) | EU approval year | EU SmPC claim(s) |
|---|---|---|---|---|
Xtandi/enzalutamide | 2012 | Yes | 2013 | Yes |
Zytiga/abiraterone | 2011 | Yes | 2011 | Yes |
Jevtana/cabazitaxel | 2010 | No | 2011 | Yes |
Xofigo/radium Ra 223 dichloride | 2013 | No | 2013 | Yes |
Provenge/sipuleucel-T | 2010 | No | 2013 | No |