FDA approves label update for nivolumab

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Nivolumab (Opdivo)
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The US Food and Drug Administration (FDA) has updated the label for nivolumab (Opdivo®) to include new dosing and administration information. Nivolumab can now be given at 480 mg infused every 4 weeks for most approved indications, in addition to the previously approved dosing schedule of 240 mg... [Read Article]
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Study confirms higher risk of infection with CB transplant

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Amandeep Godara, MD
Results of a large, retrospective analysis support the notion that patients who receive cord blood (CB) transplants have a higher risk of infection than other hematopoietic stem cell transplant (HSCT) recipients. Investigators found that CB recipients had a significantly higher risk of bacterial, viral, and fungal infections in the early post-transplant... [Read Article]
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Expanded UCB product can stand alone

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Mitchell Horwitz, MD
The expanded umbilical cord blood (UCB) product NiCord can be used as a stand-alone graft, according to research presented at the 2018 BMT Tandem Meetings. Researchers found that a single NiCord unit provided “robust” engraftment in a phase 1/2 study of patients with high-risk hematologic malignancies. NiCord recipients had quicker... [Read Article]
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Combo is preferentially active in T-cell lymphomas

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Lorenzo Falchi, MD
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A 2-drug combination has demonstrated preferential activity in T-cell lymphomas over B-cell lymphomas, according to researchers. In a small, phase 1/2 study, treatment with oral 5-azacitidine and romidepsin produced a higher overall response rate (ORR) and prolonged progression-free survival (PFS) in patients with T-cell lymphomas. “In... [Read Article]
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Brentuximab vedotin sBLA receives priority review

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Brentuximab vedotin
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The US Food and Drug Administration (FDA) has accepted for priority review a supplemental biologics license application (sBLA) for brentuximab vedotin (ADCETRIS). With this sBLA, Seattle Genetics, Inc., is seeking approval for brentuximab vedotin in combination with chemotherapy for frontline treatment of patients with advanced classical Hodgkin... [Read Article]
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