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
sNDA Submitted to FDA for Approval of Venetoclax/Obinutuzumab in Treatment Naive CLL
March 8th 2019The combination regimen of venetoclax and obinutuzumab is seeking FDA approval; a supplemental new drug application has been submitted to the FDA for the combination as a treatment for patients with previously untreated chronic lymphocytic leukemia who also have coexisting medical conditions, according to an announcement from Genentech (Roche).
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Adding Ibrutinib to CAR T-Cell Therapy Increases Response Rates in CLL
February 22nd 2019Adding ibrutinib to CAR T-cell therapy led to improved responses in patients with relapsed/refractory chronic lymphocytic leukemia, according to preliminary findings presented at the 2019 Transplantation and Cellular Therapy Meetings.
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Expert Highlights Duvelisib Benefit for Patients With CLL
February 1st 2019In an interview with <em>Targeted Oncology</em>, Ian W. Flinn, MD, PhD, discussed the potential impact of duvelisib on patients with CLL. Flinn serves as the lead investigator of the DYNAMO and DUO studies in duvelisib.
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Ibrutinib Plus Obinutuzumab Approved by FDA as Frontline CLL/SLL Treatment
January 28th 2019The combination of ibrutinib and obinutuzumab has gained FDA approval for the first-line treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, based on data from the phase III iLLUMINATE trial.
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Expert Highlights Responses Seen With Ibrutinib Plus CAR T-Cell Therapy Combination in CLL
January 10th 2019Jordan Gauthier, MD, MSc, discussed the results presented at the 2018 ASH Annual for this clinical trial and where the research is headed for patients with CLL. He also highlights another promising combination for this patient population that was presented at the meeting as well.
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Individualized-Dose Lenalidomide-Based Regimen a Possible Frontline Treatment for Advanced CLL
January 10th 2019A triplet regimen consisting of chlorambucil and rituximab in combination with an individualized dose of lenalidomide can potentially be used as a frontline treatment for patients with advanced chronic lymphocytic leukemia who are older or unfit for standard treatment with fludarabine, cyclophosphamide, and rituximab.
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