[{"orgOrder":0,"company":"Astex Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Accepts Review of NDA for Oral ASTX727 or oral C-DEC Combination","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Otsuka Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otsuka Announces Simultaneous Regulatory Approvals by U.S. FDA and Health Canada of INQOVI","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"The National Comprehensive Cancer Network","sponsor":"Taiho Oncology","pharmaFlowCategory":"D","amount":"$2.0 million","upfrontCash":"Undisclosed","newsHeadline":"NCCN Oncology Research Program, with Taiho Oncology, to Explore New Research into Oral Medication Targeting Tumor Suppression Genes","therapeuticArea":"Oncology","highestDevelopmentStatus":"Undisclosed","country":"","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Undisclosed"},{"orgOrder":0,"company":"The University of Texas MD Anderson Cancer Center","sponsor":"Astex Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Astex Pharmaceuticals and MD Anderson Collaborate to Accelerate Clinical Evaluation of Therapies for Patients with Leukemia","therapeuticArea":"Oncology","highestDevelopmentStatus":"Undisclosed","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Undisclosed"},{"orgOrder":0,"company":"Societal CDMO","sponsor":"Astex Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Recro Enters Development Agreement With Astex Pharmaceuticals","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Taiho Oncology","sponsor":"Astex Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"National Comprehensive Cancer Network\u00ae Adds INQOVI\u00ae Tablets to its Clinical Practice Guidelines in Oncology for Myelodysplastic Syndromes","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Astex Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Astex Pharmaceuticals Presents Overall Survival Data From ASCERTAIN Phase 3 Study of Oral Hypomethylating Agent INQOVI\u00ae (decitabine and cedazuridine) in MDS and CMML at International Congress on Myelodysplastic Syndromes","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Astex Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Oral Decitabine and Cedazuridine (ASTX727) Granted Orphan Drug Designation (ODD) by the European Commission for the Treatment of Acute Myeloid Leukemia (AML)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Astex Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Astex Announces that the Phase 3 ASCERTAIN - Acute Myeloid Leukemia (AML) Clinical Study of Oral Hypomethylating Agent Decitabine and Cedazuridine Fixed-Dose Combination (ASTX727 or DEC-C) Met the Trial\u2019s Primary Endpoint","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Otsuka Pharmaceutical","sponsor":"Astex Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Medicines Agency Commences Review of Oral Fixed-dose Combination of Decitabine and Cedazuridine for the Treatment of Adults With Acute Myeloid Leukemia","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"August 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Otsuka Holdings","sponsor":"Astex Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otsuka and Astex Announce that the European Commission Has Approved INAQOVI\u00ae (oral decitabine and cedazuridine) for the Treatment of Adults with Newly Diagnosed Acute Myeloid Leukaemia","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Astex Pharmaceuticals","sponsor":"Genentech","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Venetoclax Plus HMA Therapy Shows Encouraging Results in Higher-Risk MDS\/CMML","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"}]
Find Clinical Drug Pipeline Developments & Deals for Cedazuridine
Venetoclax Plus HMA Therapy Shows Encouraging Results in Higher-Risk MDS/CMML
Details:
Inqovi is a combination of decitabine, a nucleoside metabolic inhibitor, and cedazuridine, a cytidine deaminase inhibitor. It is being evaluated in combination with venetoclax for the treatment of higher-risk myelodysplastic syndromes & chronic myelomonocytic leukemia.
Inaqovi (decitabine and cedazuridine) is an orally administered, fixed-dose combination and inhibitor of cytidine deaminase, which is indicated for newly diagnosed acute myeloid leukaemia.
ASTX727 is an orally administered, fixed dose combination of the approved anti-cancer DNA hypomethylating agent, decitabine, together with cedazuridine, an inhibitor of cytidine deaminase.
ASCERTAIN - AML clinical study of decitabine and cedazuridine, as a fixed-dose combination (ASTX727), in adult patients with AML not candidates for chemotherapy demonstrated decitabine exposure equivalence of total 5-day dosing between oral ASTX727 and intravenous decitabine.
Orphan Drug Designation from EC was received on the basis of Phase1 and Phase 2 clinical trial results, for the combination of decitabine and ASTX727 (cedazuridine) for the treatment of Acute Myeloid Leukemia.
Inqovi is oral fixed-dose combination of anti-cancer Deoxyribonucleic acid hypomethylating agent, decitabine, and cytidine deaminase inhibitor, cedazuridine. Updated efficacy data demonstrated overall response rate of 62%, with 22% of patients achieving complete response.
ASTX727 is a small molecule DNMT inhibitor currently under Phase III trial. Astex and Recro expand partnership for oral solid dose drug product services.
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 in Oncology for Myelodysplastic Syndromes.
The initial focus will be on evaluating Astex’s oral decitabine and cedazuridine hypomethylating agent (INQOVI®) in combinations with other therapies. MD Anderson and Astex will design new clinical studies to be conducted at MD Anderson.
The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) plans to develop a program to scientifically evaluate and facilitate clinical trials on the efficacy of decitabine and cedazuridine. Studies will be funded by Taiho Oncology.
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