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ClinicalTrials.gov 02/21/2019 09:51
Condition : Acute Myeloid Leukemia Interventions : Drug: Idasanutlin; Drug: Cytarabine; Drug: Daunorubicin; Procedure: Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT) Sponsor : Hoffmann-La Roche Not yet recruiting.
Pharmafile 02/21/2019 07:11
Cancer biopharma firm Xencor has revealed it is to place a hold on its ongoing Phase 1 trial of XmAb14045, its investigational CD123 x CD3 bispecific antibody, in patients with relapsed or refractory acute myeloid leukaemia and other CD123-expressing hematologic malignancies after the deaths of two patients which are considered to be "at least possibly related" to the use of the drug. The deaths were originally detailed in a safety report submitted by Xencor to the FDA. read more.
WN.com 02/20/2019 09:15
CAMBRIDGE, Mass., Feb. 20, 2019 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for TIBSOVO® (ivosidenib) for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation who are not eligible for standard therapy.

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