Shots:
The EC has approved Rezurock (200mg) to treat chronic GVHD pts (≥12yrs., ≥40kg)
Approval was based on safety and efficacy clinical data, incl. the P-II (ROCKstar) trial (n=77), which showed an improved ORR of 74% in chronic GVHD pts post–stem cell transplant & after ≥2 prior systemic therapies
Under the conditional marketing authorisation, Sanofi will conduct a confirmatory randomized study
Ref:…
