publication date: Jul. 10, 2020

Drugs & Targets

Inqovi approved by FDA for at-home MDS treatment

Inqovi (decitabine and cedazuridine) has received approval for at-home treatment of adult patients with myelodysplastic syndromes and chronic myelomonocytic leukemia.

Inqovi, taken in the form of tablets, is sponsored by Astex Pharmaceuticals Inc., a subsidiary of Otsuka Pharmaceutical Co. Ltd.

Previously, patients with MDS had to visit a healthcare facility to receive intravenous therapy. 

“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,” Richard Pazdur, director of 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 in a statement. “At this critical time, we continue to focus on providing options to patients with cancer, including regimens that can be taken at home.”

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

The approval 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 eight-week period. The safety profile of Inqovi was also similar to intravenous decitabine.

FDA 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 also received Orphan Drug designation.

FDA collaborated with international agency counterparts on the review of this application as part of Project Orbis.

Continue reading Inqovi approved by FDA for at-home MDS treatment
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