Tox is­sues? Check. Ques­tion­able ef­fi­ca­cy da­ta? Check. OK to mar­ket? ODAC says check that box for Epizyme

Based on the FDA’s own in-house re­view, Epizyme doesn’t have a whole lot of ev­i­dence to prove tazeme­to­stat works well in fight­ing ep­ithe­lioid sar­co­ma, which def­i­nite­ly runs hot in trig­ger­ing se­ri­ous side ef­fects and has that FDA hold in its clin­i­cal past to raise ad­di­tion­al con­cerns.

But every­one on the On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee thought it was fine for mar­ket­ing. They vot­ed 11 to 0 to urge the FDA to give Epizyme $EPZM the green light.

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