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Agios Pharmaceuticals (AGIO) has already announced plans to seek U.S. approval for its second leukemia drug by the end of the year. On Wednesday, the biotech firm provided a peek at some of the clinical trial data that will support the new filing.

The Agios drug is called ivosidenib, and it works by blocking a mutated enzyme, IDH1, that is found in 6 to 10 percent of patients with acute myeloid leukemia (AML), a type of blood cancer that forms in the bone marrow and causes unchecked growth of abnormal white blood cells.

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  • So, if Agios is seeking end of the year filing ; is that breakthrough status ? If so, under the new FDARA Act, Race For Children , they are supposed to post expanded access policy and contact info. To allow a chance at life for those many not in their small, slow trials. Not that they shouldn’t already be doing the right moral thing , but that is lacking in PHRMA World…

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