赛诺菲移植物抗宿主病资产Rezurock获得欧盟批准建议

2026-01-30 21:51

The European Medicine Association's Committee for Medicinal Products for Human Use has given a positive recommendation for conditional approval to Sanofi's (SNY) chronic graft-versus-host disease treatment Rezurock (belumosudil).
The recommendation is for use of Rezurock when other treatments have failed or have provided limited benefit.
The positive outcome comes CHMP issued a negative opinion in October 2025.
Sanofi has agreed to conduct a confirmatory post-marketing study.
The recommendation was based on results from the randomized phase 2 ROCKstar that found durable responses with Rezurock for patients after stem cell transplant and at least two prior lines of systemic therapy.

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