https://www.targetedonc.com/view/bla-for-remestemcel-l-to-treat-pediatric-sr-agvhd-resubmitted-to-fda
Summary below of the phase 3 GVHD001/002 clinical trial (NCT02336230) which supports the BLA.
Please fix if you find holes.
Outcome Measure Result Overall Response Rate (ORR) at Day 28 70.4% Comparison to Control ORR (P-value) Exceeded control value of 45% (P = .0003) Survival Rate at Day 100 (Responders) 87% Survival Rate at Day 100 (Non-responders) 47% Comparison to Best Available Therapy Response at Day 28: 67% vs. 10% in control group Survival at Day 180: 67% vs. 10% in control group Dosage Regimen Intravenous remestemcel-L at 2 x 10^6 MSC/kg twice per week for 4 weeks Patient Eligibility Ages 2 months to 17 years, grade B-D aGVHD requiring systemic corticosteroid therapy, adequate performance status and renal function Trial Endpoints Primary: ORR at 28 days Secondary: OS at 100 days, ORR at 56 and 100 days
Cell Therapy News/Articles, page-17821
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