The U.S. Food and Drug Administration has approved Inqovi (decitabine and cedazuridine) tablets for treatment of adult patients with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML).

This is an important advance in treatment as it provides an oral treatment option for patients with MDS who previously needed to visit a health care facility to receive intravenous therapy.

Inqovi has to be taken as one tablet by mouth once daily for five consecutive days of each 28-day cycle.

The Food and Drug Administration has granted this approval to Astex Pharmaceuticals, Inc., a subsidiary of Otsuka Pharmaceutical Co. Ltd.

Myelodysplastic syndromes are a group of blood cancer in which immature blood cells in the bone marrow do not mature or become healthy blood cells.Chronic myelomonocytic leukaemia is a form of leukaemia that is characterised by high numbers of white blood cells, called 'monocytes', in the blood and bone marrow.

"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," said Richard Pazdur, M.D., 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. "At this critical time, we continue to focus on providing options to patients with cancer, including regimens that can be taken at home."

The approval by Food and Drug Administration was based on clinical trial results which showed similar drug concentrations between intravenous decitabine and Inqovi. Additionally, about half of the patients who were formerly dependent on transfusions were able to no longer require transfusions during an 8-week period. The safety profile of Inqovi was also similar to intravenous decitabine.

Some common side effects of Inqovi included fatigue, constipation, hemorrhage, muscle pain, mucositis (mouth sores), arthralgia (joint pain), nausea, and fever with low white blood cell count. Inqovi can cause fetal harm, and both male and female patients of reproductive age are advised to use effective contraception.

The Food and Drug Administration granted this application Priority Review. This review also used the Oncology Center of Excellence Assessment Aid and the Office of Pharmaceutical Quality's Assessment Aid. These are voluntary submissions from the applicant to facilitate the FDA's review. Inqovi received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

The Food and Drug Administration collaborated with international agency counterparts on the review of this application as part of Project Orbis.

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