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
Intas Pharmaceuticals Limited on FDA Import Alert List
- Plan to Initiate a Phase 1 Study of FHD-286 in Combination with Decitabine or Cytarabine in Relapsed and/or Refractory AML Patients in Q3™2023 - Clinical and Pre-Clinical Data Suggest FHD-286 Has...
TOKUSHIMA, Japan--(BUSINESS WIRE)--150 patients have been enrolled at the multi-clinical centers in US to the Phase 3 randomized trial of DFP-10917 vs non-intensive reinduction (LoDAC, Azacytidine, Decitabine, Venetoclax combo-regimens) or intensive reinduction (high and intermediate dose of Cytarabine regimens) in the 2nd, 3rd, or 4th salvage of AML and the 1st interim analysis of this study shall be done for NDA approval to the FDA in US soon after confirmation of the superiority of DFP-10917 arm. The endpoint is CR rate for primary and the Overall Survival for secondary. DFP-10917 (Radgocitabine) was granted as Orphan Drug Designation (ODD) by the FDA in US.
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.
Jiangsu Hansoh`s Generic Decitabine Receives Approval in U.S.