OMG so much reading, HC has been too active.
If FDA does NOT approve the 45% ORR as a control group (especially for patients with Grade C/D), then Jakafi approval should be revoked.
(page 96 main document)
"...Additionally, the recently approved treatment for SR-aGVHD, ruxolitinib, showed significantly poorer Day 28 OR in patients with severe disease (Glucksberg Grade III/IV) compared to those with non-severe disease. Though the overall Day 28 ORR was 55%, it was 44.4%, 40.7% and 100% in Grades IV, III, and II, respectively (Jakafi prescribing information, 2020). "
The fact that Jakafi has no efficacy in Grade IV & III, suggests that the 55% ORR was completely driven by Grade II patients in their cohort!!!!
OMG so much reading, HC has been too active. If FDA does NOT...
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