PRINCETON, N.J., Jan. 23, 2024 /PRNewswire/ -- Taiho Oncology, Inc. announces publication of the final results from the pivotal ASCERTAIN clinical trial of fixed-dose oral decitabine and cedazuridine (INQOVI®) compared to intravenous decitabine in adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML).1
Taiho Announces Presentation of Data of Oral Decitabine and Cedazuridine
Otsuka Pharma`s Inaqovi (Cedazuridine/Decitabine) Receives Approval in Europe
Otsuka and Astex announce that the European Commission has approved INAQOVI® (oral decitabine and cedazuridine) for the treatment of adults with newly diagnosed acute myeloid leukaemia
The European Medicines Agency (EMA) has accepted Otsuka Pharmaceutical and Astex Pharmaceuticals’ marketing authorisation application (MAA) for an oral fixed-dose combination of decitabine and cedazuridine (ASTX727) for the initial treatment of adults with acute myeloid leukaemia (AML) who are not candidates for standard induction chemotherapy.
PLEASANTON, Calif.--(BUSINESS WIRE)--Astex Pharmaceuticals, Inc. (Astex) today announce that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for the oral fixed-dose combination of decitabine and cedazuridine (ASTX727) for the initial treatment of adults with acute myeloid leukemia (AML) who are not candidates for standard induction chemotherapy.
PLEASANTON, Calif.--(BUSINESS WIRE)--Astex Pharmaceuticals, Inc. (“Astex”) announces today that the European Commission (EC) has granted orphan-drug designation (ODD) to the oral fixed dose combination of decitabine and cedazuridine (ASTX727) for the treatment of Acute Myeloid Leukemia (AML).
PLEASANTON, Calif.--(BUSINESS WIRE)--Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan, today announced updated clinical data, including median overall survival (mOS), from the ASCERTAIN phase 3 trial of INQOVI®, the company’s orally administered fixed-dose combination of decitabine and cedazuridine (ASTX727 or DEC-C) in adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML). mOS was 31.7 months.
PRINCETON, N.J., Nov. 23, 2020 /PRNewswire/ -- Taiho Oncology, Inc. today announced that the FDA approved hypomethylating agent INQOVI® (decitabine and cedazuridine) 35 mg/100 mg tablets, for oral use, has been included in the latest National Comprehensive Cancer Network® Clinical Practice Guidelines (NCCN Guidelines®) in Oncology for Myelodysplastic Syndromes (MDS). The NCCN Guidelines now include a category 2a recommendation that oral decitabine and cedazuridine (DEC-C) could be considered as a substitution for intravenous decitabine in the treatment of adult patients with MDS.1
PLEASANTON, Calif.--(BUSINESS WIRE)-- Astex Pharmaceuticals, Inc. a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd., based in Tokyo, Japan, today announces it has entered into a Cooperative Research and Development Agreement with the U.S. National Cancer Institute, part of National Institutes of Health. The agreement calls for a range of new clinical and translational studies of oral decitabine and cedazuridine tablets as an anticancer agent to be conducted in collaboration with Astex. The NCI’s Cancer Therapy Evaluation Program (CTEP) has announced they are accepting Letters of Intent for evaluation of oral decitabine and cedazuridine tablets in hematological malignancies and solid tumors, including in combination with other investigational agents. Study proposals will be reviewed by CTEP and by Astex.