trending Market Intelligence /marketintelligence/en/news-insights/trending/ebyqrfhorkokqbvv3ozsvw2 content esgSubNav
In This List

Agios Pharmaceuticals' leukemia drug gets priority review from US FDA

Blog

Baird Research is Now Exclusively Available in S&P Global’s Aftermarket Research Collection

Blog

Japan M&A By the Numbers: Q4 2023

Blog

Essential IR Insights Newsletter Fall - 2023

Case Study

A Corporation Clearly Pinpoints Activist Investor Activity


Agios Pharmaceuticals' leukemia drug gets priority review from US FDA

Agios Pharmaceuticals Inc. said the U.S. Food and Drug Administration granted priority review status to its blood cancer drug, ivosidenib.

The Cambridge, Mass.-based biotech company had submitted the application to the FDA in December 2017, with data supported by an early stage clinical trial.

Ivosidenib, also known as AG-120, is intended to treat acute myeloid leukemia patients whose disease has either returned or is resistant to treatment and exhibits the isocitrate dehydrogenase-1, or IDH1, mutation.

Acute myeloid leukemia is a cancer of the myeloid line of blood cells, characterized by the rapid growth of abnormal cells that build up in the bone marrow and blood and interfere with normal blood cells.

The FDA will make a decision on whether it will approve the treatment by Aug. 21.