Список проголосовавших за комментарий " <table class="BriefingDataTable" border="0" cellspacing="0" cellpadding="0"><tr> <td class="tickerColumn"> </td> <td class="articleColumn">Agios Pharma and Celgene (CELG) announce that the FDA has accepted and granted priority review for the NDA for enasidenib for the treatment of patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase 2 mutation (48.44)<p>The NDA was granted Priority Review and has been given a Prescription Drug User Fee Act (PDUFA) action date of Aug. 30, 2017. Celgene completed the NDA submission in late December 2016. Enasidenib is part of Celgene's global strategic collaboration with Agios focused on cancer metabolism.</p><ul><li>Celgene additionally disclosed that Abbott (<strong>ABT</strong>) has submitted a Premarket Approval (PMA) application for the FDA approval of an IDH2 assay on the Abbott m2000 RealTime System, a polymerase chain reaction (PCR) molecular diagnostics instrument. IDH2 mutations occur in about 8 to 19 percent of AML patients.</li><li>Celgene is also evaluating enasidenib compared with conventional therapy in older patients with an IDH2 mutation and relapsed or refractory AML in the ongoing phase III IDHENTIFY trial (NCT02577406).</li></ul></td> </tr></table>"