Gemtuzumab Ozogamicin for Pediatric Acute Myeloid Leukemia: Alan S. Gamis, MD, MPH

In this interview, Alan S. Gamis, MD, MPH, speaks with i3 Health about the recent FDA approval of gemtuzumab ozogamicin (MylotargTM, Wyeth Pharmaceuticals, LLC) for pediatric patients aged 1 month and older with newly diagnosed CD33-positive acute myeloid leukemia (AML). Dr. Gamis, lead investigator of the phase 3 Children's Oncology Group Trial AAML0531, which provided the basis for the approval, discusses the significance of the approval and shares his advice for health care providers as they ...
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Gemtuzumab Ozogamicin Approved for Pediatric Acute Myeloid Leukemia

The FDA has extended the approval of gemtuzumab ozogamicin (MylotargTM, Wyeth Pharmaceuticals, LLC) to include pediatric patients aged 1 month and older with newly diagnosed CD33-positive acute myeloid leukemia (AML). Gemtuzumab ozogamicin is a humanized immunoconjugate that targets CD33, a cell surface antigen present in over 80% of patients with AML. The approval was based on AAML0531 (NCT00372593), a phase 3 trial that enrolled 1,063 patients aged 0 to 29 years with newly diagnosed AML. Patie...
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Treosulfan/Fludarabine Conditioning Improves Outcomes in HSCT

A recent phase 3 trial found that treosulfan/fludarabine used as conditioning treatment prior to allogeneic hematopoietic stem cell transplantation (HSCT) led to greater event-free survival compared with busulfan/fludarabine in older or comorbid patients with acute myeloid leukemia or myelodysplastic syndrome. While patients age 50 or older with acute myeloid leukemia or myelodysplastic syndrome are often considered eligible for allogeneic HSCT, they are at increased risk from standard myeloabla...
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Acute Myeloid Leukemia: OS Data Approved for Gilteritinib

The FDA has now approved the addition of data on overall survival (OS) to the labeling of gilteritinib (Xospata®, Astellas Pharma US, Inc.), which is indicated for adults with previously treated acute myeloid leukemia (AML) with an FLT3 mutation. These new data demonstrate that gilteritinib has been successful in increasing OS. One of the types of leukemia occurring most frequently in adults, AML is still fairly rare, representing around 1% of all cancers. According to American Cancer Society es...
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First-Line Ivosidenib Approved for Older Patients With AML

The FDA has now approved ivosidenib (Tibsovo®, Agios Pharmaceuticals, Inc.) as a first-line treatment for patients 75 years or older with acute myeloid leukemia (AML) and a susceptible IDH1 mutation who have comorbidities that prevent them from safely using intensive induction chemotherapy. Ivosidenib has previously been approved for patients with AML with no comorbidities. However, AML is mainly a disease found in older adults; nearly a third of all AML cases are diagnosed in those older than 7...
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