FDA's ODAC shrugs off ob­jec­tions to Mesoblast's GVHD drug for chil­dren, vot­ing 9-1 in fa­vor and im­prov­ing the odds of an ap­proval

The FDA’s On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee once again waved through an in­ves­ti­ga­tion­al drug, clear­ing the po­ten­tial fi­nal hur­dle be­fore the agency’s de­ci­sion.

Thurs­day’s win­ner was Mesoblast $MESO, an Aus­tralian stem-cell com­pa­ny that sub­mit­ted its Ry­on­cil drug for the treat­ment of steroid re­frac­to­ry acute graft-ver­sus-host dis­ease in chil­dren younger than 12. ODAC gave Ry­on­cil the thumbs up by a 9-1 vote, shrug­ging off con­cerns about tri­al de­sign and push­ing aside the need for an ad­di­tion­al study.

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