Entries by Peggy Bickerton

ASCO Annual Meeting

ASCO Annual Meeting (ASCO will not proceed in person.  The conference will take place using a virtual format. Please visit the ASCO website for more information.) 29 May- 2 June 2020 Chicago, IL visit conference website

Astex Pharmaceuticals announces U.S. Food and Drug Administration (FDA) acceptance for review of an NDA for the combination oral hypomethylating agent cedazuridine and decitabine (ASTX727 or oral C-DEC), for the treatment of MDS and CMML

NDA is supported by data from the phase 3 ASCERTAIN study of oral C-DEC in adults with intermediate- and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML) FDA designated the application for Priority Review Potential for oral C-DEC to become first approved orally administered hypomethylating agent for MDS and CMML in the U.S. Pleasanton, […]

Astex Pharmaceuticals presents topline data from the ASCERTAIN phase 3 study of its novel, oral hypomethylating agent cedazuridine and decitabine (ASTX727) in MDS and CMML at the American Society of Hematology Meeting in Orlando, FL.

The study achieved its primary objective of decitabine systemic exposure equivalence between oral ASTX727 and IV decitabine with an oral/IV ratio of approximately 99% Safety findings were consistent with those anticipated for IV administered decitabine; the most common Adverse Events were hematological. Astex plans to file a New Drug Application (NDA) with the US FDA […]

Taiho Oncology Announces Agreement with Otsuka to Commercialize Astex Pharmaceuticals’ Drug Candidates

PRINCETON, N.J., June 7, 2019 – Taiho Oncology, Inc. announces that it has assumed commercialization responsibility from Otsuka Pharmaceuticals Co., Ltd., (Otsuka) for the novel fixed-dose combination of cedazuridine and decitabine (ASTX727) and guadecitabine (SGI-110) in the U.S. and Canada, subject to regulatory approvals. Taiho Pharma Canada, Inc., will commercialize these compounds in Canada. The […]

Astex Pharmaceuticals and Otsuka announce results of the phase 3 ASCERTAIN study of the novel oral cedazuridine and decitabine fixed-dose combination (ASTX727) in patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML)

Cedazuridine and decitabine, administered orally as a fixed-dose combination (ASTX727), met the primary endpoint of decitabine exposure equivalence of total 5-day dosing between oral ASTX727 and IV decitabine in the phase 3 ASCERTAIN study in MDS and CMML patients The study confirmed that the safety profile and clinical activity of the cedazuridine and decitabine fixed-dose […]