October 17th 2024
The FDA granted galinpepimut-S a rare pediatric disease designation for the treatment of pediatric patients with acute myeloid leukemia.
FDA Approves Olutasidenib for Relapsed/Refractory IDH1+ Acute Myeloid Leukemia
December 2nd 2022Positive and durable complete responses observed with olutasidenib in adult patient with relapsed or refractory acute myeloid leukemia and a susceptible IDH1 mutation have led the FDA to grant approval to the drug for this group of patients
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Lintuzumab-Ac225 and Intensive Chemotherapy Elicits High Response Rates in AML
November 3rd 2022The phase 1 study of lintuzumab-Ac225 combined with the CLAG-M regimen in acute myeloid leukemia demonstrated positive response rates, including an overall survival rate of 53% at 1-year and 32% at 2-years.
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FDA Issues Final Guidance on Developing Drugs for Treatment of AML
October 25th 2022The FDA has released their final guidance for developing drugs and biological products for the treatment of patients with acute myeloid leukemia. This focuses on the end points in which sponsors and clinicians should consider when looking at these new agents.
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FDA Grants Priority Review to Quizartinib NDA for FLT3-ITD–Positive AML
October 24th 2022Based on data from the phase 3 QuANTUM-First trial, the FDA has accepted and granted priority review to the new drug application for quizartinib for patients with FLT3-ITD-positive acute myeloid leukemia.
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Magrolimab Development Continues for the Treatment of AML and MDS
October 4th 2022In an interview with Targeted Oncology, Naval G. Daver, MD, discussed the approved and investigational CD47 monoclonal antibodies for patients with acute myeloid leukemia and myelodysplastic syndrome and where research is taking this space.
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Ivosidenib Plus Azacitidine Improves Survival and Responses in IDH1-Mutated AML
September 29th 2022Results from the phase 3 AGILE study presented at SOHO 2022 show that ivosidenib plus azacitidine prolong event-free and overall survival with good responses vs placebo in patients with IDH1-mutated acute myeloid leukemia
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Menin Inhibitors Have Potential to Become the Next Class of Targeted Therapy in AML
August 31st 2022In an interview with Targeted Oncology, Eunice S. Wang, MD, discussed the growing use of menin inhibitors in acute myeloid leukemia, and clinical trial research further supporting the treatment strategy.
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