May 8th 2024
A phase 3 study evaluating uproleselan in relapsed/refractory acute myeloid leukemia missed its primary end point of overall survival.
Community Practice Connections™: Real-World Applications of Novel Therapies Across TNBC and Addressing Disparities in Care
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6th Annual Precision Medicine Symposium: An Illustrated Tumor Board
October 18-19, 2024
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Advances in TNBC: Communicating with Your Patients About Clinical Trial Awareness and Treatment Concerns to Improve Clinical Outcomes
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Community Practice Connections™: 5th Annual Precision Medicine Symposium – An Illustrated Tumor Board
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Novel Radiolabeled ADC Being Explored for Older Patients with AML
April 6th 2018Studies have shown that older patients with either active, relapsed, or refractory acute myeloid leukemia have had lower survival rates, poor risk assessments, and limited therapeutic options. The standard care of these patients is salvage chemotherapy. Investigators are pretreating patients in this high-risk population with Iomab-B, a novel radiolabeled antibody–drug conjugate as part of a stem cell transplantation regimen in hopes of improving remission and survival outcomes.
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MRD Associated With Worse Outcomes in AML
April 4th 2018According to results published in <em>The New England Journal of Medicine</em>, molecular minimal residual disease was associated with a higher rate of relapse and a lower rate of relapse-free survival and overall survival for patients with newly-diagnosed acute myeloid leukemia.
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A Look Back at FDA News in the Month of March
April 3rd 2018Several new indications were approved by the FDA in March, including blinatumomab (Blincyto) for MRD+ ALL, brentuximab vedotin (Adcetris) for Hodgkin lymphoma, and a 4-week nivolumab (Opdivo) dosing schedule across several indications. Here’s a look back on the FDA happenings for the month of March 2018.
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A Look Back at FDA News in the Month of February
March 3rd 2018New indications were approved by the FDA within the last month, including abemaciclib for HER2-negative breast cancer, durvalumab for non–small cell lung cancer, and abiraterone acetate for castration-sensitive prostate cancer.
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Expert Reflects on Exciting Year of AML Approvals and Looks Ahead to Active Areas of Research
February 28th 2018The treatment paradigm of acute myeloid leukemia has not changed much in the last several decades, but with 4 new drugs approved by the FDA within the span of a few months, 2017 easily became the most promising year yet for the treatment of AML.
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Ivosidenib Granted Priority Review Designation by FDA for IDH1+ AML
February 15th 2018Based on findings from a phase I trial presented at the 2017 ASH Annual Meeting, ivosidenib (AG-120) has been granted a priority review designation by the FDA for the treatment of patients with relapsed/refractory <em>IDH1</em>-mutant acute myeloid leukemia.
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Arsenic Trioxide Approved by FDA for Promyelocytic Leukemia
January 17th 2018Arsenic trioxide (Trisenox) has been approved by the FDA in combination with the all-trans retinoic acid agent tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia with the t(15;17) translocation or <em>PML-RARA</em> gene expression.
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Optimizing FLT3 Inhibitor Monotherapy in Acute Myeloid Leukemia
December 27th 2017Acute myeloid leukemia (AML) therapy is guided mainly by cytogenetic profile, such as chromosomal duplication or deletion, and molecular mutations. <em>FLT3</em> mutations are the most common genetic abnormalities detected in patients with AML and are usually associated with a high relapse rate and short overall survival. Given the dismal outcomes in patients with <em>FLT3</em>-mutant AML, a great effort has been underway over the last several years to develop clinically effective FLT3 inhibitors.
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Ivosidenib Submitted for FDA Approval in IDH1+ AML
December 27th 2017Based on results of a phase I trial presented at the 2017 ASH Annual Meeting, a new drug applicaton for ivosidenib has been submitted for FDA approval for the treatment of patients with relapsed/refractory IDH1-mutant acute myeloid leukemia, according to a statement from Agios Pharmaceuticals, the company developing the targeted therapy.
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Nilotinib Label for CML Updated by FDA With Discontinuation Provision
December 26th 2017The label for nilotinib (Tasigna) has been updated by the FDA with a provision stating patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) who have received the BCR-ABL tyrosine kinase inhibitor could be eligible to stop treatment after having recieved for at least 3 years and having achieved the specific predetermined criteria.<br /> <br />
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Ivosidenib Demonstrates Responses in More Than 40% in Relapsed/Refractory IDH+ AML
December 16th 2017Ivosidenib (AG-120), an IDH1 inhibitor, demonstrated an objective response rate (ORR) of 41.6% in patients with relapsed/refractory <em>IDH1</em>-mutant acute myeloid leukemia (AML), according to findings from a single-arm phase I study.
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Savoldo Receives Grant for Immunotherapy Research from The Leukemia & Lymphoma Society
December 1st 2017The Leukemia & Lymphoma Society (LLS) has awarded Barbara Savoldo, MD, PhD, with a $600,000, 3-year grant in support of her promising research into a CAR T-cell treatment with a “safety switch” that could alleviate potential side effects for patients with acute lymphoblastic leukemia being treated with the immunotherapy.
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James R. Downing to Receive ASH's 2017 E. Donnall Thomas Lecture Prize
November 28th 2017The American Society of Hematology has announced that James R. Downing, MD, of St. Jude Children’s Research Hospital will be awarded the 2017 E. Donnall Thomas Lecture and Prize for his discoveries related to the hematopathology and molecular biology of childhood leukemia.
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Midostaurin Granted EU Approval for AML, Advanced Systemic Mastocytosis
September 20th 2017Midostaurin has received approval from the European Commission as a treatment for adults with newly diagnosed <em>FLT3</em>-positive acute myeloid leukemia and advanced systemic mastocytosis, including aggressive systemic mastocytosis, SM with associated hematological neoplasm, and mast cell leukemia.
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Building on the Success of BCL-2 Inhibition in AML
September 18th 2017Understanding of the role of BCL-2 in acute myeloid leukemia (AML) continues to evolve, even as BCL-2–targeted therapy improves outcomes in the disease, AML specialist Daniel Pollyea, MD, MS said at the 2017 Society of Hematologic Oncology Annual Meeting in Houston, Texas.
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