It is also worth considering the Phase III trials that FDA and EMEA approved for validating pomalidomide.
US P III compares Pom+Vd vs Vd, which I interpret as conceding that Pom+Dex has answered the question of its efficacy and safety profile in Velcade/RLI refractory patients, so the next question is how does the triplet compare to the doublet.
EMEA-approved P III would never be run in the United States due to the relative futility of the control arm. It compares Pom+Dex vs High Dose Dex. One research report suggested the control arm will progress in 2-3 months and a KOL I asked at ASCO2012 said perhaps 1-2 months. There is strong enthusiasm on both sides of the pond for pomalidomide and France already has an Expanded Access Program.
