FDA Approves Oral Combination of Dacogen and Cedazuridine for Patients with Myelodysplastic Syndromes – Curetoday.com

The Food and Drug Administration approved the oral combination of Inquovi (Dacogen [decitabine] and cedazuridine) for certain adult patients with myelodysplastic syndromes (MDS).

In both trials, patients were split into two groups: one group received Inqovi (35 mg of Dacogen and 100 mg cof edazuridine) orally in cycle 1 and decitabine 20 mg/m2 intravenously in cycle 2, while the second group received the reverse sequence.

Both Inqovi and intravenous Dacogen were administered once daily on days one through five of a 28-day cycle. Starting with cycle 3, all patients received Inqovi orally once daily on days one through five of each 28-day cycle until disease progression or unacceptable toxicity.

In the first trial, investigators found a complete response (CR) rate of 18% and median duration of CR of 8.7 months. The second trial demonstrated that 21% of patients achieved CR. The median duration of CR was 7.5 months.

The most common side effects that occurred in 20% or more of patients included fatigue, constipation, hemorrhage, myalgia, mucositis, arthralgia, nausea, dyspnea, diarrhea, rash, dizziness, febrile neutropenia, edema, headache, cough, decreased appetite, upper respiratory tract infection, pneumonia and increased transaminase.

The most common grade 3 or 4 laboratory abnormalities, which occurred in 50% or more of patients, were leukocytes decreased, platelet count decreased, neutrophil count decreased and hemoglobin decreased. The overall safety profile of oral Inqovi was similar to IV decitabine.

The overall safety profile of oral Inqovi was similar to IV Dacogen.

The recommended Inqovi dose is one tablet (35 mg Dacogen and 100 mg cedazuridine) orally on an empty stomach once daily on days one through five of each 28day cycle.

Check back later for what you need to know about this approval.

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FDA Approves Oral Combination of Dacogen and Cedazuridine for Patients with Myelodysplastic Syndromes - Curetoday.com