Venetoclax Combo Approved for Older Patients With Acute Myeloid Leukemia

The FDA has now granted full approval to venetoclax (Venclexta®, AbbVie Inc. and Genentech Inc.) in combination with azacitidine, decitabine, or low-dose cytarabine (LDAC) for patients with previously untreated acute myeloid leukemia (AML) who are at least 75 years of age or who have comorbidities that prevent them from receiving intensive induction chemotherapy. Previously, this venetoclax combination therapy was granted accelerated approval in 2018 for use in this same patient population. The ...
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In Acute Myeloid Leukemia, Measurable Residual Disease Correlates With Survival

Measurable residual disease correlates with disease-free survival and overall survival data for patients with acute myeloid leukemia (AML), according to results of a meta-analysis published today in JAMA Oncology. This finding supports the continued use of measurable residual disease as a surrogate end point in clinical trials. The investigators, led by first author Nicholas Short, MD, Assistant Professor in the Department of Leukemia at the University of Texas MD Anderson Cancer Center in Houst...
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Acute Myeloid Leukemia: Oral Azacitidine Maintenance Approved

The FDA has now approved azacitidine tablets (Onureg®, Celgene) for the maintenance treatment of acute myeloid leukemia (AML) after intensive induction chemotherapy in patients who are unable to complete intensive curative therapy and who have achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi). The approval was based on data from the multicenter, double-blind phase 3 QUAZAR trial (NCT01757535), in which 472 patients with AML who achieved CR or CRi w...
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Sorafenib Maintenance Effective at Preventing Relapse in Acute Myeloid Leukemia

Sorafenib maintenance after transplant has shown to be effective in decreasing chance of relapse for patients with acute myeloid leukemia (AML) that have a FLT3 internal tandem duplication (FLT3-ITD) and who are undergoing allogeneic hematopoietic stem-cell transplantation (HSCT), according to recent phase 3 study results published in The Lancet Oncology. A total of 202 patients with FLT3-ITD AML were enrolled. To be eligible, patients had to be aged 18 to 60 years old, currently undergoing allo...
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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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