FDA Approves Inqovi®, New Oral Treatment for Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)

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

Since it is taken orally, Inqovi provides an option for people with MDS or CMML to take their medication at home instead of visiting a healthcare facility to receive intravenous (IV) treatment.¹

Inqovi is for adults with MDS that has been previously treated and untreated, de novo and secondary, with the following French-American-British (FAB) classifications:

• Refractory anemia
• Refractory anemia with ringed sideroblasts
• Refractory anemia with excess blasts
• CMML

Inqovi is also for people whose MDS is classified by the International Prognostic Scoring System (IPSS) as intermediate-1, intermediate-2, or high-risk.

How does Inqovi work?

Inqovi is a combination of two drugs, decitabine, and cedazuridine.

Decitabine is a chemotherapy drug that kills abnormal cells in bone marrow by stopping cell reproduction. When the abnormal cells cannot divide and grow, they die. Cedazuridine belongs to a class of drugs called cytidine deaminase inhibitors. It prevents the breakdown of important enzymes in the body. When taken with decitabine, it balances enzymes in the digestive tract.

Inqovi in clinical trials

Inqovi was studied in 2 open-label, randomized, crossover clinical trials that included 213 total patients. Patients in these studies were given either Inqovi or IV decitabine for the first cycle, then given the other medication for the second cycle. All patients received Inqovi on the third cycle. The studies found similar drug concentrations between Inqovi and IV decitabine. Additionally, about half of the patients who were previously transfusion dependent no longer needed transfusions during the 8-week follow-up period.²

What are the side effects of Inqovi?

The side effects of Inqovi can vary based on what the drug is used for. For people taking Inqovi for MDS and CCML, the most common side effects include:¹

• Constipation or diarrhea
• Cough
• Fatigue
• Headache
• Hemorrhage
• Low blood cell counts, including red blood cells and white blood cells
• Pneumonia

These are not all the possible side effects of Inqovi. Patients should talk to their doctor about what to expect with treatment with Inqovi.

Things to know about Inqovi

Inqovi can lower the number of red and white blood cells in the body. This can lead to an increased risk of infection. Inqovi can also lower the number of platelets in the body. Low numbers of platelets can increase a person’s risk of serious bleeding.

Tell your doctor about any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

Inqovi may harm an unborn baby. Because of this, effective birth control is needed while taking the drug. Inqovi may also pass through breast milk, so women taking Inqovi are advised not to breastfeed.¹

Read the prescribing information.