Oh I forgot to mention that Ruxolitinib was approved for SR-aGVHD based on ORR, the result was published in NJEM, but buried in the supplemental figure is the Overall Survival. Again, there is NO DIFFERENCE in OS 2 years out from initiation.
As if this is not adding salt to the wound, Ruxolitinib was also recently approved by the FDA for the treatment of Chronic GVHD, again, the primary endpoint was met but guess what? There is no difference in Survival.
If anyone talks to the FDA, please ask them why Rux is approved with no CLEAR Demonstration of survival benefit, AND Clear evidence of Toxicity? Also, anyone have access to NEJM should ask the same question. Clearly, the primary endpoint chosen by the manufacturer is inadequate to demonstrate efficacy of the drug in both of these conditions. Maybe the FDA should look into Rux, just like how they have a discussion with PI3K drugs.
Oh I forgot to mention that Ruxolitinib was approved for...
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