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On July 21, 2021, the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to venetoclax (in combination with azacitidine) for the treatment of adult patients with previously untreated intermediate- to very high-risk myelodysplastic syndromes (MDS).1 This approval was based on the results of the phase Ib M15-531 study.
Venetoclax has previously been approved for combination treatment of newly diagnosed acute myeloid leukemia (AML), previously untreated chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL), and for previously treated CLL.
MDS are a group of hematologic malignancies that alter the ability of the bone marrow to produce normal blood cells. Patients with MDS often feel weak, suffer from frequent infections, anemia, and fatigue which can reduce their quality of life. MDS can progress to AML, and the median survival of higher-risk MDS is approximately 18 months.1
As mentioned above, the FDA granted venetoclax in combination with azacitidine breakthrough therapy designation following the interim results from the M15-531 study.1 This designation aims to accelerate the development of medicines for the treatment of serious conditions based on preliminary evidence demonstrating an improvement over existing treatment options. Higher-risk MDS is associated with reduced quality of life, a poor prognosis, and has limited therapeutic options. This designation has the potential to improve outcomes for patients with MDS.
ASCO 2019 | What are the current challenges facing AML treatment?
At the 2019 ASCO Annual Meeting in Chicago, US, Tapan M. Kadia from MD Anderson Cancer Center, Houston, US, discusses the current challenges facing AML treatment.
Five new powerful weapons against AML
This quintet of new drugs is likely to reshape the therapeutic landscape of AML. patients and physicians will now have the help of several new recruits in their fight against this lethal blood cancer.
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