Probably helpful in looking a little closer at the FDA approval for Ruxolitinib in over 12 year olds now, to compare their results with out results.
FDA comments on Ruxolitinib for GvHD
Ruxolitinib - Open label with placebo arm
Overall response rate = 70%, control* = 57%, Improvement in response = 22.8%
*63% Grade C/D
Remestemcel-L - Open label with historical arm ( CIBMTR database )
Overall response rate = 70.4%, control* = 45% , Improvement in response = 56%
* 88% Grade C/D
Ruxolitinib - Improvement in 1 year or 2 year survival
Nil -1 year survival 49% vs control 44% ( Not scientifically significant )
Nil -2 year survival 38% vs control 36% ( Not scientifically significant )
Remestemcel-L - Improvement in 1 year or 2 year survival
50% survival increase - 1 year survival 63% vs CIBMTR Control 42% ( Ruxolitinub 44% )
46% survival increase - 2 year survival 51% vs CIBMTR Control 35% ( Ruxolitinub 36% )
Ruxilinib - Median duration of the treatment response
4.2 months vs 2.1 months BAT, 100% increase over BAT
Remestemcel-L - Median duration of the treatment response
Appears to be infinite increase over BAT, due to 50% survival increase at 4 years
Response is permanent to 4 years
2023 The Final Countdown, page-1763
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