WASHINGTON — The FDA approved an oral combination of decitabine and cedazuridine (Inqovi) for the treatment of adults with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML).
The new treatment comes in tablet form, which patients take by mouth once daily for five consecutive days for each 28-day cycle. This treatment will eliminate the need for patients to receive intravenous therapy at a health care facility.
The fact that patients can receive their treatment at home is critical, the FDA noted, during the Covid-19 pandemic.
“The approval was based on clinical trial results which showed similar drug concentrations between intravenous decitabine and Inqovi, ” the FDA wrote in its statement about the approval. “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.”
There are side effects with the treatment, the most common of which are fatigue, constipation, hemorrhage, muscle pain, muscositis, arthralgia, nausea, and fever with low white blood cell count.
Men and women of child-breaing age should use contraception, as the drug can harm fetuses, the FDA added.
Inqovi was given Priority Review and was reviewed as part of the FDA’s international collaboration, Project Orbis.
Astex Pharmaceuticals, Inc, a subsidiary of Otsuka Pharmaceutical Co. Ltd, manufactures combination decitabine and cedazuridine.
Candace Hoffmann, Managing Editor, BreakingMED™
Cat ID: 118
Topic ID: 78,118,730,118,120,466,192,925
