FDA Approves Inqovi, a New Oral Combination Therapy, for Patients with MDS

On July 7, 2020, the FDA approved decitabine plus cedazuridine (Inqovi; Astex Pharmaceuticals) tablets for the treatment of adults with intermediate- or high-risk myelodysplastic syndromes, 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. The FDA granted Inqovi a priority review and an orphan drug designation. Inqovi is the first and only orally administered hypomethylating agent approved for the treatment of this patient population.

The FDA approval of decitabine plus cedazuridine was based on data from the phase 3 clinical trial ASCERTAIN, which compared the efficacy and safety of 5-day administration of oral decitabine plus cedazuridine versus intravenous (IV) decitabine, as well as on supporting data from phase 1 and phase 2 clinical trials. Findings from these trials showed similar drug concentrations between the 2 treatments. In addition, approximately 50% of the patients who were previously dependent on transfusions no longer required transfusions during an 8-week period.

“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 health care facilities. At this critical time, we continue to focus on providing options to patients with cancer, including regimens that can be taken at home,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence.

The most common (≥20%) adverse reactions with Inqovi treatment 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 increased transaminase. The most common (>50%) grade 3 or 4 laboratory abnormalities were decreases in leukocytes, platelet count, neutrophil count, and hemoglobin levels.

Serious adverse reactions (>5%) with Inqovi therapy included febrile neutropenia (30%), pneumonia (14%), and sepsis (13%). Adverse events leading to death included sepsis (1%), septic shock (1%), pneumonia (1%), respiratory failure (1%), and 1 case each of cerebral hemorrhage and sudden death.

Related Articles

Subscribe to
Oncology Practice Management

Stay up to date with oncology news & updates by subscribing to recieve the free OPM print publications or weekly e‑Newsletter.

I'd like to recieve: