November 20th 2024
The FDA updated the fludarabine phosphate injection labeling under Project Renewal, clarifying the dosage for combination therapy and streamlining safety warnings.
November 13th 2024
Idelalisib: A PI3K Inhibitor on the Horizon
January 9th 2014Idelalisib is a potent and highly selective PI3K inhibitor that promotes apoptosis in primary cells from patients with different B-cell malignancies. Idelalisib has been shown to affect microenvironmental signaling and cell survival both in vitro and in vivo.
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Efficacy and Safety of Idelalisib and Rituximab for Previously Treated CLL
January 8th 2014Richard R. Furman, MD, Richard A. Stratton Assistant Professor in Hematology and Oncology, Weill Cornell Medical College, gives an overview of the efficacy and safety of idelalisib and rituximab for previously treated CLL.
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Idelalisib Improves Outcomes in Heavily-Pretreated CLL
December 14th 2013A combination of rituximab (Rituxan) and the PI3K-delta inhibitor idelalisib was associated with a >70% improvement in overall survival (OS) in patients with high-risk relapsed/refractory chronic lymphocytic leukemia (CLL).
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Updated Data Continues to Back Ibrutinib in CLL
December 13th 2013At the 55th Annual Meeting of the American Society of Hematology (ASH), several trials of ibrutinib both alone and in combination with currently used therapies for patients with chronic lymphocytic leukemia (CLL) were presented.
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Frontline Ofatumumab Efficacious in Older CLL Patients
December 11th 2013In patients with previously untreated chronic lymphocytic leukemia (CLL) who are considered inappropriate for fludarabine, the addition of ofatumumab to chlorambucil improves clinical outcomes and is tolerable irrespective of patient age or fitness.
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A Preview of the 2013 ASH Annual Meeting
December 5th 2013Marcel R.M. van den Brink, MD, PhD, Head, Division of Hematologic Oncology, Alan N. Houghton Chair, Memorial Sloan-Kettering Cancer Center, highlights two studies that will be presented at the 2013 American Society of Hematology (ASH) Meeting.
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Frontline Obinutuzumab (Gazyva) Approved for CLL
November 1st 2013Obinutuzumab (Gazyva) plus chlorambucil has been approved by the FDA as a first-line treatment for patients with CLL, based on clinical trial data demonstrating that the combination more than doubled median PFS over the chemotherapy agent alone.
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Ponatinib Trial Discontinued Following Occurrence of Arterial Thrombotic Events
October 21st 2013A phase III EPIC trial exploring ponatinib (Iclusig) in untreated patients with chronic myeloid leukemia (CML) has been discontinued. The decision comes following a high occurrence of arterial thrombotic events, according to a statement released by Ariad Pharmaceuticals, Inc., the company developing the drug.
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Ofatumumab Receives Breakthrough Therapy Designation for Earlier Use in CLL
October 16th 2013The monoclonal antibody ofatumumab (Arzerra) has received Breakthrough Therapy designation from the FDA that could allow for earlier use in patients with chronic lymphocytic leukemia (CLL), according to a joint announcement released by GlaxoSmithKline and Genmab, who are developing and distributing the drug.
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FDA Grants Breakthrough Therapy Designation for Volasertib
September 18th 2013The FDA has granted a Breakthrough Therapy designation to the novel PLK1 inhibitor volasertib in combination with LDAC for its potential as a treatment for patients with untreated AML who are ineligible for intensive remission induction therapy.
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