Shots:
- The CHMP has recommended Rezurock (200mg) for conditional approval in chronic GVHD pts (≥12yrs., ≥40kg), with EC’s decision expected in the coming wks.
- Opinion was supported by extensive clinical data, incl. the P-II (ROCKstar) trial, which showed an improved ORR of 74% in chronic GVHD pts post–stem cell transplant & after ≥2 prior systemic therapies
- Under CHMP’s positive opinion, Sanofi will conduct a confirmatory randomized study & will continue evaluating Rezurock in additional age groups & indications, incl. pediatric chronic GVHD (≥1yr.) & chronic lung allograft dysfunction
Ref: Globenewswire | Image: Sanofi | Press Release
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