Inqovi, an Oral Therapy for Myelodysplastic Syndromes, Gets FDA Approval

The administration of cedazuridine with decitabine prevents the degradation of decitabine by CDA in the gastrointestinal tract and liver increasing its systemic exposure.

The Food and Drug Administration (FDA) has approved Inqovi® (decitabine, cedazuridine tablets; Taiho Oncology) 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 a fixed-dose combination of decitabine, a nucleoside metabolic inhibitor, and cedazuridine, a cytidine deaminase (CDA) inhibitor. The administration of cedazuridine with decitabine prevents the degradation of decitabine by CDA in the gastrointestinal tract and liver increasing its systemic exposure.  

The approval was based on data from an open-label, randomized, crossover phase 1/2 study (Study ASTX72701-B) and a phase 3 study (ASCERTAIN). The studies included a total of 213 adults with MDS or CMML who were randomized 1:1 to receive either Inqovi (decitabine 35mg, cedazuridine 100mg) orally in Cycle 1 and decitabine 20mg/m2 intravenously (IV) in Cycle 2 (administered once daily on days 1 through 5 of the 28-day cycle) or the reverse sequence. Starting with Cycle 3, all patients received Inqovi until disease progression or unacceptable toxicity.

Results from the studies showed similar drug concentrations between Inqovi and IV decitabine. The geometric mean ratio of the 5-day cumulative decitabine area under the curve following 5 consecutive once daily doses of Inqovi compared with that of IV decitabine was 99% (90% CI, 93-106). Moreover, approximately half of the patients who were previously dependent on transfusions at baseline became independent of red blood cell and platelet transfusions during any 56-day post baseline period. 

With regard to safety, Inqovi had a similar profile to that of IV decitabine. The most common adverse reactions observed with Inqovi 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 were decreased leukocytes, decreased platelet count, decreased neutrophil count, and decreased hemoglobin. 

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Inqovi tablets are supplied in a 5-count blister card. Each tablet contains decitabine 35mg and cedazuridine 100mg. Inqovi should not be substituted for an IV decitabine product within a cycle.

Commenting on the approval, Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said: “The FDA remains committed to providing additional treatments to patients during the coronavirus pandemic. In this case, the FDA is making available an oral outpatient treatment option that can reduce the need for frequent visits to healthcare facilities.” 

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