Drugs / ASTX727
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed acute megakaryoblastic leukemia in adult 1 milestone | |||||
| Filed | EU (EMA) | — | acute megakaryoblastic leukemia in adult | 2022-08-22 | “EMA has accepted the Marketing Authorisation Application (MAA) for the oral fixed-dose combination of decitabine and cedazuridine (ASTX727)” otsuka.co.jp ↗ |
| Filed chronic myelomonocytic leukemia 1 milestone | |||||
| Filed | US (FDA) | — | chronic myelomonocytic leukemia | 2020-02-11 | “FDA acceptance for review of an NDA for the combination oral hypomethylating agent cedazuridine and decitabine (ASTX727 or oral C-DEC)” taihooncology.com ↗ |
Trials 13
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 2026-06-11 | Syndax Pharmaceuticals | Results Syndax Showcases Revuforj® (revumenib) Clinical Activity in Multiple Acute Leukemia Subtypes and Settings at EHA 2026 syndax.com ↗
Ph 2 SAVE trial of revumenib with venetoclax and decitabine/cedazuridine in R/R NPM1m, KMT2Ar, or NUP98r AML shows 88% (37/42) ORR, 68% (25/37) MRD negativity among responders, and 45% (19/42) transplant rate |
| 2026-06-03 | Taiho Oncology, Inc. | Results Taiho Oncology Announces New England Journal of Medicine Publication of First All-Oral Regimen in Newly Diagnosed Acute Myeloid Leukemia taihooncology.com ↗
The study demonstrated favorable response rates and survival with expected myelosuppressive effects. |
| 2026-05-14 | Taiho Oncology, Inc. | Regulatory INQOVI®とvenetoclax併用療法を米国FDAが承認 強力な寛解導入療法が適さない急性骨髄性白血病患者さんに対する初の経口薬のみの併用療法として taiho.co.jp ↗
INQOVIとvenetoclaxの併用療法は、 本患者集団に対する初めてかつ唯一の経口剤のみによる併用療法として承認され、 頻回の通院を必要とする注射剤のDNAメチル化阻害剤ベースの治療レジメンに代わる治療選択肢を提供します. |
| 2026-05-14 | Taiho Oncology, Inc. | Regulatory U.S. FDA Approves INQOVI® in Combination with Venetoclax, the First All-Oral Combination Treatment for Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive Induction Chemotherapy taiho.co.jp ↗
INQOVI in combination with venetoclax is the first and only all-oral combination treatment regimen approved for this patient population, offering an alternative to parenteral hypomethylating agent–based regimens that require frequent clinic visits. |
| 2026-05-13 | Taiho Oncology, Inc. | Regulatory U.S. FDA Approves INQOVI® in Combination with Venetoclax, the First All-Oral Combination Treatment for Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive Induction Chemotherapy taihooncology.com ↗
INQOVI in combination with venetoclax is the first and only all-oral combination treatment regimen approved for this patient population, offering an alternative to parenteral hypomethylating agent–based regimens that require frequent clinic visits. |
| 2026-05-12 | Syndax Pharmaceuticals | Results Syndax Highlights 12 Revuforj® (revumenib) Abstracts Accepted for EHA 2026, Advancing Leadership in Menin Inhibition syndax.com ↗
We also look forward to sharing additional frontline and R/R combination data showing high rates of MRD negativity, transplant, and favorable tolerability, supporting physician decision making and our ongoing pivotal trials. |
| 2025-07-09 | Taiho Oncology, Inc. | Regulatory Taiho Oncology and Taiho Pharmaceutical Announce U.S. FDA Acceptance of Supplemental New Drug Application for INQOVI® in Combination with Venetoclax to Treat Patients with Acute Myeloid Leukemia taihooncology.com ↗ |
| 2024-12-09 | Taiho Oncology, Inc. | Results Taiho Oncology Data at ASH Annual Meeting Highlight Progress in Oral Therapies for Patients with Blood Cancers taihooncology.com ↗
In addition, results of a real-world study comparing clinical outcomes with INQOVI® (decitabine and cedazuridine) tablets, an oral hypomethylating agent (HMA), versus intravenous (IV) or subcutaneous (SC) decitabine and azacitidine, respectively, were shared in a poster presentation. |
| 2024-12-07 | Syndax Pharmaceuticals | Results Syndax Presents Positive Revuforj® (revumenib) Data in Acute Leukemias from Multiple Trials, Including the SAVE Combination and AUGMENT-101 Trials, at 66th ASH Annual Meeting syndax.com ↗
82% ORR (27 of 33 pts) and 48% CR/CRh (16 of 33 pts) in SAVE trial studying revumenib in combination with venetoclax and decitabine/cedazuridine in R/R AML |
| 2024-11-05 | Syndax Pharmaceuticals | Results Syndax Announces Revumenib Abstracts to Be Presented at the 66th ASH Annual Meeting syndax.com ↗
The most common (>20%) Grade ≥3 TEAEs were febrile neutropenia (46%) and lung infection (42%), while Grade ≥3 TRAEs (any agent) were thrombocytopenia (12%), neutropenia (8%), QT prolongation (8%), and DS (4%). |
| 2024-01-23 | Taiho Oncology, Inc. | Results Taiho Oncology Announces Publication of Final Results of the Phase 3 ASCERTAIN Clinical Trial of Oral Decitabine and Cedazuridine Fixed Dose Combination (INQOVI®) in Patients With MDS and CMML taihooncology.com ↗
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). |
| 2023-12-10 | Taiho Oncology, Inc. | Results Taiho Oncology Announces Presentation of Data From a U.S. Real-World Study of Oral Decitabine and Cedazuridine taihooncology.com ↗
Taiho Oncology, Inc. announced results of a U.S. real-world study of oral decitabine and cedazuridine (DEC-C) in patients with myelodysplastic syndromes (MDS), a rare form of blood cancer. |
| 2023-11-02 | Syndax Pharmaceuticals | Results Syndax Announces Updated Data Supporting Impressive Clinical Profile of Revumenib in Genetically-Defined Acute Leukemias to Be Presented at the 65th ASH Annual Meeting syndax.com ↗
Seven of eight patients were response-evaluable, and all seven attained a morphologic remission (overall response rate of 100%). |
| 2023-09-19 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory 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 ® otsuka.co.jp ↗
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 chemotherapy. |
| 2022-12-12 | Taiho Oncology, Inc. | Results 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 taihooncology.com ↗
The median OS (mOS) in patients treated with ASTX727 with biallelic vs. monoallelic mutations was 13.0 months (95% Confidence Interval [CI]: 5.3, 29.1) vs. 29.2 months (95% CI: 19.8, NE). |
| 2022-08-22 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory European Medicines Agency commences review of oral fixed-dosecombination of decitabine and cedazuridine for the treatment ofadults with acute myeloid leukemia otsuka.co.jp ↗
Otsuka Pharmaceutical Europe Ltd. (Otsuka) and 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 leukaemia (AML) who are not candidates for standard induction chemotherapy. |
| 2021-09-23 | Taiho Oncology, Inc. | Results 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 taihooncology.com ↗
mOS was 31.7 months. |
| 2020-07-08 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka announces simultaneous regulatory approvals by U.S. FDA and Health Canada of INQOVI, an oral hypomethylating agent (HMA) therapy for MDS and CMML® otsuka.co.jp ↗
INQOVI is the first and only orally administered hypomethylating agent approved in the U.S. and Canada for the treatment of MDS and CMML. |
| 2020-07-07 | Taiho Oncology, Inc. | Regulatory Astex Pharmaceuticals, Taiho Oncology, and Otsuka Pharmaceutical announce FDA and Health Canada approval of INQOVI® (decitabine and cedazuridine) tablets, oral hypomethylating agent (HMA) therapy for intermediate and high-risk MDS and CMML taihooncology.com ↗
Astex Pharmaceuticals, Inc.; Taiho Oncology, Inc.; and Otsuka Pharmaceutical Co., Ltd. today announce that the U.S. Food and Drug Administration (FDA) and Health Canada have approved INQOVI® (decitabine and cedazuridine) tablets. |
| 2020-02-11 | Taiho Oncology, Inc. | Regulatory 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 taihooncology.com ↗
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 |
| 2019-06-07 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Otsuka and its Subsidiary Astex Pharmaceuticals, Inc. Announce Positive Results from a Phase III Clinical Trial of Anticancer Candidate ASTX727 otsuka.co.jp ↗ |
| 2016-11-29 | Astex Pharmaceuticals, Inc. | Results Astex to Showcase Its Next-Generation Hypomethylating Agents Being Developed for Treatment of AML/MDS at the 2016 Annual Meeting of the American Society of Hematology astx.com ↗
Successful Emulation of IV Decitabine Pharmacokinetics with an Oral Fixed-Dose Combination of the Oral Cytidine Deaminase Inhibitor (CDAi) E7727 with Oral Decitabine, in Subjects with Myelodysplastic Syndromes (MDS): Final Data of Phase 1 Study (Abstract #114). |
All press releases naming this drug 24 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ASTX727 | “subjects will receive treatment with ASTX727, 1 tablet/day for 5 consecutive days, in 28-day cycles.” NCT06091267 ↗13“ASTX727 is a combination of cedazuridine and decitabine.” NCT07012044 ↗ |
| Action | Inhibit | “(DNMT) inhibitor ASTX727” NCT06177171 ↗ |
| Route | Oral | “ASTX727 (replacement of guadecitabine to an oral dose tablet)” NCT02998567 ↗ |