FDA-Approved Oral Hypomethylating Agent Regimen Excites MDS Landscape

Guillermo Garcia-Manero, MD, professor and chief of Section of Myelodysplastic Syndromes, Department of Leukemia at The University of Texas MD Anderson Cancer Center, and principal investigator of the ASCERTAIN trial, discusses how the recently approved combination regimen of decitabine and cedazuridine (Inqovi) fits into the treatment landscape for patients with myelodysplastic syndromes (MDS).

The indication for this approval is for patients with previously treated or untreated de novo and secondary MDS and patients with intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups, including those with refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia.

This approval is going to be very important, says Garcia-Manero. It is exciting because this is a new approach for patients with MDS. Hypomethylating agent compounds have been used for many years, so it is almost automatic how prescriptions are written, which means this will be a challenge, but in a good way, he says.

Garcia-Manero says patients will demand this drug more now that it has received its approval in July 2020 since these are oral tablets compared with intravenous injections.

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