Agios spot­lights promis­ing da­ta for IDH1 drug, putting it on the path to FDA sub­mis­sion

Agios to­day played a few of the cards it plans to show the FDA lat­er this year when it files for an ap­proval of its IDH1 drug ivosi­denib.

Just a few months since the FDA hand­ed out an OK for the IDH2 drug Id­hi­fa, which Cel­gene large­ly con­trols, Agios $AGIO says in its ASH ab­stract that the first group of 125 pa­tients in their piv­otal study of acute myeloid leukemia demon­strat­ed a com­plete re­sponse rate of 21.6%, with 8.8% see­ing a CR with par­tial hema­to­log­ic re­cov­ery.

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