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NEWS

Orca Bio’s Tregzi Wins FDA Approval for Allogeneic Transplant in Adults with Hematological Malignancies

Shots: The US FDA has approved Tregzi (Orca-T) for use in a stem cell transplant to improve survival free of chronic graft versus host disease (GVHD) in adults with hematological malignancies  Approval was backed by the P-III (Precision-T) trial assessing Orca-T + TAC vs conventional alloHSCT in pts (n=187) with acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, &…
July 1, 2026

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Sanofi
NEWS

Sanofi Reports the EC Approval of Rezurock (Belumosudil) to Treat Chronic Graft-vs-Host Disease (GVHD) 

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:…
March 26, 2026

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