Items Tagged ‘FDA. BTD’

August 9th, 2016

Pracinostat Receives Breakthrough Therapy Designation from FDA for Treatment in Combination with Azacitidine of Patients with Newly Diagnosed Acute Myeloid Leukemia

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The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the investigational drug Pracinostat in combination with azacitidine for the treatment of elderly patients with newly diagnosed acute myeloid leukemia (AML). Acute myeloid leukemia (AML) is a cancer of the bone marrow (spongy portion found in the middle of bones) and blood […]

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Tags: Acute Myeloid Leukemia, AML, azacitidine, Breakthrough Therapy Designation, elderly, FDA. BTD, HDACs, Leukemia, News, Pracinostat


July 19th, 2016

Loxo Oncology Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for LOXO-101

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Loxo Oncology, Inc. (LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-101, a selective inhibitor of tropomyosin receptor kinase (TRK), “for the treatment of unresectable or metastatic solid tumors with NTRK-fusion […]

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Tags: All Cancer Types, Breakthrough Therapy Designation, FDA. BTD, General, LOXO-101, metastatic solid tumors, News, TRK fusions, unresectable