November 27th 2024
LBS-007, a novel targeted therapy, has received FDA fast track designation for the treatment of acute myeloid leukemia.
November 25th 2024
November 15th 2024
November 14th 2024
November 12th 2024
Kulke Appointed Chief of Hematology/Oncology at BUMC
January 12th 2018Boston University Medical Center has announced that Matthew Kulke, MD, will serve as its chief of the Section of Hematology/Oncology in the Department of Medicine, effective March 1, 2018. Kulke will also obtain the roles of deputy director of the BU-BMC Cancer Center, medical director of the Clinical Cancer Center at BMC, and the Zoltan Kohn Professor of Medicine at the Boston University School of Medicine.
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Superior PFS Maintained Over Time With Daratumumab in Relapsed/Refractory Myeloma
January 11th 2018According to an updated analysis of the POLLUX trial, progression-free survival remained superior over time in patients with relapsed/refractory multiple myeloma treated with combination therapy that included the anti-CD38 antibody daratumumab.
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Results for Ipilimumab and Nivolumab Following Autologous Stem Cell Transplant in Multiple Myeloma
January 11th 2018Andrew L. Pecora, MD, President of the Physician Services Division and Chief Innovation Officer at Hackensack Meridian Health, discusses preliminary safety and efficacy data for combined checkpoint inhibition with ipilimumab (Yervoy) and nivolumab (Opdivo) as consolidation therapy following autologous stem cell transplant in patients with multiple myeloma and non-Hodkin lymphoma.
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Results for Atezolizumab, Obinutuzumab, and Bendamustine in Follicular Lymphoma
January 5th 2018Anas Younes, MD, Chief of Lymphoma Service, Memorial Sloan Kettering Cancer Center, discusses the interim analysis of a study exploring the safety and efficacy of atezolizumab (Tecentriq) in combination with obinutuzumab (Gazya) and bendamustine in patients with previously untreated follicular lymphoma.
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Denosumab Granted FDA Approval for Multiple Myeloma
January 5th 2018Based on data from the phase III 482 study, denosumab (Xgeva) has been granted FDA approval for the prevention of skeletal-related events in patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor.
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Frontline Eltrombopag Receives FDA's Breakthrough Therapy Designation for Severe Aplastic Anemia
January 5th 2018Eltrombopag (Promacta) has been granted a breakthrough therapy designation by the FDA for use in combination with standard immunosuppressive therapy for the first-line treatment of patients with severe aplastic anemia.
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A Look Back at FDA News in the Month of December
January 3rd 2018The FDA closed out the year by approving several new agents last month, including bevacizumab for glioblastoma, cabozantinib for renal cell carcinoma, nivolumab for melanoma, bosutinib for chronic myeloid leukemia, and pertuzumab for HER2+ breast cancer. In addition, several agents were granted a priority review designation. Here is a look back at all the FDA activity that took place in December.
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Frontline Brentuximab Vedotin Receives FDA's Priority Review for Hodgkin Lymphoma
January 3rd 2018Based on findings from the phase III ECHELON-1 trial, a supplemental biologics application (sBLA) for brentuximab vedotin (Adcetris) in combination with Adriamycin, vinblastine, and dacarbazine (AVD) has been granted a priority review by the FDA for the frontline treatment of advanced classical Hodgkin lymphoma, according to a statement from the company developing the CD30-targeted antibody-drug conjugate, Seattle Genetics.
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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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