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# FDA Approves Astex’ Inqovi for MDS, CMML Patients
- URL: https://www.fdaweb.com/fda-approves-astex-inqovi-for-mds-cmml-patients/
- Published: 2020-07-07T12:00:00.000Z
- Updated: 2026-09-14T16:20:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147142

FDA has approved Astex Pharmaceuticals’ Inqovi (decitabine and cedazuridine) tablets to treat adults with myelodysplastic syndromes and chronic myelomonocytic leukemia. An agency [statement](https://www.prnewswire.com/news-releases/fda-approves-new-therapy-for-myelodysplastic-syndromes-mds-that-can-be-taken-at-home-301089489.html?ref=fdaweb.com) says the approval “represents an important advance in treatment options for patients with MDS, a type of blood cancer, who previously needed to visit a healthcare facility to receive intravenous therapy.”

FDA says the approval was based on clinical trial results that 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 eight weeks, it says. The safety profile of Inqovi was also similar to intravenous decitabine, according to the statement.

Some common side effects of Inqovi included fatigue, constipation, hemorrhage, muscle pain, mucositis, arthralgia, nausea, and fever with low white blood cell count.

FDA granted the application priority review and it also used the Oncology Center of Excellence Assessment Aid and the Office of Pharmaceutical Quality Assessment Aid. Inqovi also received orphan drug designation.

The agency says it collaborated with international agency counterparts on the review of the application as part of Project Orbis.