Entries by Peggy Bickerton

Taiho Oncology and Astex Pharmaceuticals Announce Data Presentations at the 65th ASH Annual Meeting

Real-world evidence on use of oral decitabine and cedazuridine in the treatment of myelodysplastic syndromes to be featured in an oral presentation; results of several additional studies in hematological malignancies were accepted for poster presentations Princeton, N.J., and Pleasanton, Calif., November 17, 2023 – Taiho Oncology Inc. and Astex Pharmaceuticals, Inc. announced today details of […]

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

LONDON, UK, and PLEASANTON, CA, USA, 19th September 2023 – Otsuka Pharmaceutical Europe Ltd. (Otsuka) and Astex Pharmaceuticals, Inc. (Astex) today announce that the European Commission (EC) has approved INAQOVI® (oral decitabine and cedazuridine) as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction […]

Taiho Oncology and Astex Pharmaceuticals Present Overall Survival Data for Oral Decitabine and Cedazuridine (INQOVI®, ASTX727) in Patients With MDS and CMML Harboring TP53 Mutations at 64th ASH Annual Meeting

Patients in Phase 3 ASCERTAIN study with biallelic TP53 mutations achieved median overall survival (mOS) of 13 months; mOS in the overall study population was 32 months  Results indicate potential utility of this oral hypomethylating agent in patients with MDS harboring a TP53 mutation, which is an independent prognostic factor for poor outcomes PRINCETON, N.J. […]

European Medicines Agency commences review of oral fixed-dose combination of decitabine and cedazuridine for the treatment of adults with acute myeloid leukemia

PLEASANTON, CA, USA 22 August 2022 – 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. […]

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’s primary endpoint

The phase 3 ASCERTAIN – AML clinical study of decitabine and cedazuridine, administered orally as a fixed-dose combination (ASTX727), in adult patients with AML not candidates for standard induction chemotherapy demonstrated decitabine exposure equivalence of total 5-day dosing between oral ASTX727 and intravenous (IV) decitabine Data from the study will be presented on June 10, […]

Oral decitabine and cedazuridine (ASTX727) granted Orphan Drug Designation (ODD) by the European Commission for the treatment of Acute Myeloid Leukemia (AML)

PLEASANTON, CA, 6th January, 2022 – 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)1. ODD is granted by the EC to medicinal products intended for the treatment, prevention […]

Astex Pharmaceuticals Presents Overall Survival Data From ASCERTAIN Phase 3 Study of Oral Hypomethylating Agent INQOVI® (decitabine and cedazuridine) in MDS and CMML at International Congress on Myelodysplastic Syndromes

Study achieved median overall survival of 31.7 months Updated efficacy data demonstrated an overall response rate of 62%, with 22% of patients achieving a complete response INQOVI is the only oral hypomethylating agent with equivalent exposure to its intravenous (IV) form Pleasanton, CA, September 23, 2021. Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka […]