FDA's ODAC votes unan­i­mous­ly that fu­ture PI3K in­hibitors should in­clude ran­dom­ized da­ta for blood can­cers

A pan­el of FDA’s out­side ad­vi­sors unan­i­mous­ly vot­ed, with one ab­sten­tion, that fu­ture ap­provals of PI3K in­hibitors should be sup­port­ed by ran­dom­ized da­ta.

The 17-mem­ber ODAC pan­el was asked by fed­er­al reg­u­la­tors to dis­cuss ob­served tox­i­c­i­ties of the Phos­phatidyli­nos­i­tol-3-ki­nase in­hibitor class and whether ran­dom­ized sur­vival da­ta are need­ed to sup­port risk-ben­e­fit eval­u­a­tions in pa­tients with blood can­cers. They re­turned, af­ter lis­ten­ing to agency pre­sen­ters, with a re­sound­ing “Yes.”

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