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FDA Approvals, News & UpdatesMyelodysplastic Syndromes

FDA Approves Inqovi for Patients with High-Risk Myelodysplastic Syndromes

On July 7, 2020, the FDA approved Inqovi (decitabine plus cedazuridine; from Astex Pharmaceuticals and Taiho Oncology) tablets for the treatment of adults with intermediate- or high-risk myelodysplastic syndromes, or MDS, including patients with chronic myelomonocytic leukemia. Inqovi is an orally administered fixed-dose combination of the hypomethylating agent decitabine plus the cytidine deaminase inhibitor cedazuridine.
ASCO 2020 Highlights

On July 7, 2020, the FDA approved Inqovi (decitabine plus cedazuridine; from Astex Pharmaceuticals and Taiho Oncology) tablets for the treatment of adults with intermediate- or high-risk myelodysplastic syndromes, or MDS, including patients with chronic myelomonocytic leukemia. Inqovi is an orally administered fixed-dose combination of the hypomethylating agent decitabine plus the cytidine deaminase inhibitor cedazuridine.

Inqovi is the first and only orally administered hypomethylating drug approved for the treatment of patients with one of these conditions. The FDA approved Inqovi based on data from the phase 3 ASCERTAIN study as well as supporting data from phase 1 and phase 2 clinical trials.

The ASCERTAIN study compared the benefit and safety of 5-day administration of oral Inqovi and intravenous (IV) Dacogen (decitabine).

“Intravenous or subcutaneous administered hypomethylating agents have been the cornerstone for the treatment of patients with MDS and myelomonocytic leukemia since the mid-2000s,” said Guillermo Garcia-Manero, MD, Professor and Chief of Section of Myelodysplastic Syndromes, Department of Leukemia, M.D. Anderson Cancer Center, Houston, Texas, and lead investigator of the ASCERTAIN clinical trial.

“The FDA’s approval of Inqovi builds on the proved therapeutic utility of hypomethylating agents in these diseases and offers a new orally administered option that offers patients an alternative to 5 consecutive days of IV infusions every month during a treatment period that can extend to several months,” he added.

The most common side effects with Inqovi therapy were 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 increases.

The most common serious side effects included febrile neutropenia, pneumonia, and sepsis. The most common serious laboratory test abnormalities were decreases in leukocytes, platelet count, neutrophil count, and hemoglobin levels.

Several patients died from treatment-related side effects, including 1 patient each from sepsis, septic shock, pneumonia, respiratory failure, and cerebral hemorrhage.

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Last modified: October 13, 2020

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