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FDA Approves New Therapy for Myelodysplastic Syndromes (MDS) That Can Be Taken at Home

FDA Approves New Therapy for Myelodysplastic Syndromes (MDS) That Can Be Taken at Home

Last Reviewed : 01/05/2021
FDA Approves New Therapy for Myelodysplastic Syndromes (MDS) That Can Be Taken at Home

Press Release:

The U.S. Food and Drug Administration approved Inqovi (decitabine and cedazuridine) tablets for treatment of adult patients with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML). This represents an important advance in treatment options for patients with MDS, a type of blood cancer, who previously needed to visit a health care facility to receive intravenous therapy.

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 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.

Source: U.S. Food and Drug Administration. 

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