After a delayed approval, treosulfan’s manufacturer is hopeful the alkylating agent will become the new gold standard in the United States.
, a Medexus executive said the company is “optimistic” that treosulfan will become the new “gold standard” in the United States for the indication “as it in Europe and Canada,” where the alkylating agent is already on the market.
Approval in the United States was delayed for several years pending FDA’s request for additional information regarding treosulfan’s pivotal phase 3 trial, dubbed The trial included European adults with acute myeloid leukemia or myelodysplastic syndromes undergoing transplant. They were randomly assigned about equally to intravenous fludarabine with either treosulfan at 30 g/mat 6.4 mg/kg IV, which is a reduced-intensity dose of busulfan widely used in older patients or in those with comorbidity., fatigue, infections, and febrile neutropenia.
The phase 3 trial reported equal distribution of such adverse events between the treosulfan and busulfan study arms. M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email:FDA Review Skeptical of ALS Stem Cell Therapy Ahead of Panel MeetingAll material on this website is protected by copyright, Copyright © 1994-2025 by WebMD LLC.
Hematopoietic Stem Cell Transplant Stem Cell Transplantation Stem Cell Therapy Haematopoietic Stem Cell Transplant Hematopoietic Stem Cell Transplantation (HSCT) Haematopoietic Stem Cell Transplantation (HSCT) Stem Cell Research And Therapy Transplantation Of Stem Cells Transplantation Of Hematopoietic Stem Cells Stem Cell HSCT Acute Leukemia
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