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
Notable CR Rate Induced by Moxetumomab Pasudotox in Relapsed/Refractory Hairy Cell Leukemia
June 4th 2018According to results presented at the 2018 ASCO Annual Meeting, moxetumomab pasudotox, a first-in-class recombinant immunotoxin targeting CD22, demonstrated deep and durable responses in a substantial proportion of pretreated patients with relapsed/refractory hairy cell leukemia.
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High MRD-Negative Responses Achieved With Upfront Ibrutinib/Venetoclax for CLL
June 4th 2018Treatment-naive patients with chronic lymphocytic leukemia achieved high rates of minimal residual disease–negative status of 77% with peripheral blood testing after 6 cycles from treatment with ibrutinib (Imbruvica) and venetoclax (Venclexta). Additionally, patients in the CAPTIVATE trial, wihch was presented during the 2018 ASCO Annual Meeting, achieved an objective response rate of 100%.
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Ibrutinib/Obinutuzumab Combo Improves PFS in CLL
May 25th 2018According to topline results from the phase III ILLUMINATE trial, the combination of ibrutinib and obinutuzumab improved progression-free survival compared with chlorambucil plus obinutuzumab in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
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Current Salvage Therapy Options for Relapsed/Refractory CLL
May 11th 2018Neil E. Kay, MD, professor of medicine at the Mayo Clinic, addresses the “Big 4” in salvage therapies for patients with relapsed/refractory chronic lymphocytic leukemia, including a newer therapy coming down the pipeline now.
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Rituximab/Bendamustine Combo Demonstrates Promising Results in Fludarabine-Ineligible CLL
May 7th 2018According to results from the MABLE trial, the combination of rituximab plus bendamustine demonstrated significant value as a frontline treatment option for fludarabine-ineligible patients with chronic lymphocytic leukemia.
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Memory T Cells May Predict Response to CAR T-Cell Therapy in CLL
May 4th 2018Results from a recent study conducted at the University of Pennsylvania may demonstrate why some patients with chronic lymphocytic leukemia are resistant to tisagenlecleucel, while potentially providing a pathway to enhance patient response.
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Bendamustine/Rituximab is an Effective Salvage Therapy in CLL
May 2nd 2018The combination of bendamustine and rituximab induced a 12-month progression-free survival of 78.6% for patients with chronic lymphocytic leukemia, suggesting that the combination is an effective first salvage regimen.
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A Look Back at FDA News in the Month of April
May 1st 2018The FDA approved several indications throughout the month of April 2018. A number of drugs were granted priority review and Fast Track designation. The FDA also halted all clinical trials using tazemetostat as treatment, and new initiatives were introduced to help ease the development of genetic and genomic-based tests. Check out our list of all FDA happenings from April 2018.
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