Cel­gene is squeez­ing the trig­ger on an ear­ly FDA fil­ing for key Agios can­cer drug

Six years af­ter Cel­gene helped get the R&D ball rolling at Agios with a world­wide pact that cov­ered the glob­al rights for its promis­ing AG-221, the big biotech is tee­ing up a straight shot at an ac­cel­er­at­ed ap­proval for acute myeloid leukemia based af­ter plan­ning an ear­ly look at ef­fi­ca­cy da­ta.

In an SEC fil­ing out this morn­ing, Agios re­ports that lat­er to­day Cel­gene will re­view a plan to file for an ear­ly ap­proval on AML be­fore the end of this year. And Agios it­self is prep­ping a plan to hus­tle an NDA to the FDA next year for a quick OK on AG-120, a close­ly re­lat­ed IDH1 mu­ta­tion ther­a­py which Cel­gene re­cent­ly hand­ed back in a deal to re­work their long­stand­ing col­lab­o­ra­tion.

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