FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Agios Wins Breakthrough Status for Rare Blood Cancer Treatment

April 4, 2019
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Cambridge, Mass.-based biotech firm Agios Pharmaceuticals was granted a breakthrough designation for its rare blood cancer treatment Tibsovo (ivosidenib).

The FDA awarded the designation for Tibsovo in combination with azacytidine to treat patients 75 years or older who have been newly diagnosed with acute myeloid leukemia.

Agios submitted data from a Phase I/II study that showed Tisbovo and azacytidine helped elder blood cancer patients keep their neutrophil and platelet counts up. In fact, 13 out of the 23 patients in the trial showed a complete response to the combination treatment.

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