The FDA has granted pracinostat a breakthrough therapy designation for use in combination with azacitidine as a treatment for patients with newly diagnosed acute myeloid leukemia (AML) who are aged ≥75 years or ineligible for intensive chemotherapy.
The designation, which will expedite the review and development of pracinostat, is based on a phase II trial in which the median overall survival (OS) was 19.1 months and the complete response (CR) rate was 42% with the pracinostat combination in treatment-naïve elderly patients with AML.
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