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Inqovi FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 16, 2020.

FDA Approved: Yes (First approved July 7, 2020)
Brand name: Inqovi
Generic name: decitabine and cedazuridine
Dosage form: Tablets
Company: Astex Pharmaceuticals, Taiho Oncology, and Otsuka Pharmaceutical
Treatment for: Myelodysplastic Syndrome

Inqovi (decitabine and cedazuridine) is a nucleoside metabolic inhibitor and cytidine deaminase inhibitor combination indicated for the treatment of adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML).

  • Inqovi is indicated for the treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
  • Inqovi is taken orally once daily on Days 1 through 5 of each 28-day cycle. Tablets should be taken on an empty stomach.
  • Common adverse reactions (incidence ≥ 20%) include fatigue, constipation, hemorrhage, myalgia, mucositis, arthralgia, nausea, dyspnea, diarrhea, rash, dizziness, febrile neutropenia, edema, headache, cough, decreased appetite, upper respiratory tract infection, pneumonia, and transaminase increased.

Development timeline for Inqovi

Jul  7, 2020Approval FDA Approves Inqovi (decitabine and cedazuridine) for Myelodysplastic Syndromes (MDS) including Chronic Myelomonocytic Leukemia (CMML)
Dec  9, 2019Astex Pharmaceuticals Presents Topline Data from the ASCERTAIN Phase 3 Study of its Novel, Oral Hypomethylating Agent Cedazuridine and Decitabine (ASTX727) in MDS and CMML
Jun  6, 2019Astex 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)

Further information

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