Ascentage Pharma Receives US, EU Approvals for Study of Potential Myelodysplastic Syndrome Treatment
MT Newswires Live
Aug 18
Ascentage Pharma (AAPG) said Sunday it has received clearance from the US Food and Drug Administration and the European Medicines Agency to conduct a phase 3 study of its drug lisaftoclax in combination with azacitidine for the treatment of patients with newly diagnosed higher-risk myelodysplastic syndrome.
The study is now enrolling patients at participating centers in China, the US and Europe, the company said.
The randomized, double-blind study marks the second registrational phase 3 study of the drug to receive clearance from both the FDA and EMA, the company said.
Myelodysplastic syndrome is a disease originating from hematopoietic stem cells that can lead to acute myeloid leukemia.
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