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
Responses to Zanubrutinib Monotherapy Continue and Deepen in CLL, Updated Results Show
June 16th 2021With longer follow-up, significant responses were still observed with the BTK inhibitor zanubrutinib as a single agent in patients with relapsed or refractory chronic lymphocytic leukemia in the phase 2 BGB-3111-205 trial.
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Frontline Venetoclax and Obinutuzumab Maintains Delay of Progression in CLL
June 15th 2021With further follow-up from the phase 3 CLL14 trial, the median progression-free survival was still reached with the fixed-dose regimen of venetoclax and obinutuzumab in patients with previously untreated chronic lymphocytic leukemia.
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Responses Achieved With Zandelisib/Zanubrutinib in R/R CLL, B-Cell Lymphomas
June 14th 2021A combination of zandelisib and zanubrutinib induced significant responses, including several complete responses in patients with relapsed or refractory chronic lymphocytic leukemia and other B-cell lymphomas in a phase 1b study, the results of which were presented during the 2021 European Hematology Association Annual Congress.
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Acalabrutinib Mirrors PFS Results of Ibrutinib in Frontline CLL
June 14th 2021In an interview with Targeted Oncology, Peter Hillmen, MD, PhD, discussed the results of the head-to-head trial comparing acalabrutinib and ibrutinib, as well as future directions for Bruton's tyrosine kinase inhibitors in chronic lymphocytic leukemia.
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Fixed-Duration Ibrutinib/Venetoclax Shows Greater PFS in CLL
June 12th 2021A fixed duration of ibrutinib plus venetoclax led to a significant progression-free survival benefit over chlorambucil plus obinutuzumab as frontline treatment in patients with chronic lymphocytic leukemia, according to a primary analysis of the phase 3 GLOW study presented at the European Hematology Association 2021 Virtual Congress.
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First-Line Treatment Ibrutinib Plus Venetoclax Inhibits Response in CLL/SLL
June 7th 2021Over half, 56%, of patients with chronic lymphocytic leukemia and small lymphocytic lymphoma who were treated with The combination of ibrutinib plus venetoclax produced a complete response and complete response with incomplete bone marrow recovery
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Frontline Ibrutinib/Venetoclax Combination Induces Responses in CLL/SLL
June 7th 2021Patients with chronic lymphocytic leukemia and small lymphocytic lymphoma treated with the combination of ibrutinib plus venetoclax had complete response and complete response with a 56% incomplete bone marrow recover rate in the phase 2 CAPTIVATe study.
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Frontline Ibrutinib Sustains OS Benefit in Chronic Lymphocytic Leukemia
June 5th 2021Based on 7-year follow-up data, the use of front-line ibrutinib monotherapy has sustained progression-free survival and overall survival benefit compared with chlorambucil as treatment of patients with chronic lymphocytic leukemia.
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FDA Accepts BLA for Ublituxumab and Umbralisib for Chronic Lymphocytic Leukemia
May 25th 2021The FDA has accepted the biologic license application (BLA) for ublituximab in combination with umbralisib for the treatment of patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.
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Real-World Study Shows Limited Implementation of Recommended Biomarker Testing in CLL
May 4th 2021In an interview with Targeted Oncology, Mato, a hematologic oncologists and the director of the CLL Program at Memorial Sloan Kettering Cancer Center, discussed biomarker testing in CLL, and the future of BTK inhibitors in the CLL paradigm.
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Prior Comorbidities Predict Risk of Treatment-Emergent Atrial Fibrillation in CLL
May 3rd 2021Roughly 4% of patients with chronic lymphocytic leukemia treated with ibrutinib may experience atrial fibrillation, but their comorbidities, rather than their CLL-related factors, predict risk of treatment-emergent AF.
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Zanubrutinib Shown Noninferior to Ibrutinib for Patients With R/R CLL/SLL
April 29th 2021The use of zanubrutinib was found to be noninferior to treatment with ibrutinib for adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, meeting the primary end point of the phase 3 ALPINE trial.
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Ibrutinib Extends PFS in Patients with TP53-Mutated Chronic Lymphocytic Leukemia
March 30th 2021In an interview with Targeted Oncology, John N. Allan, MD, a hematology oncologist at Weill Cornell Medicine, discussed how ibrutinib extends PFS in patients with CLL. He also discussed combination therapy in the future of CLL treatment.
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Rolling BLA for Ublituximab and Umbralisib in CLL Completed for FDA Submission
March 29th 2021The rolling submission of a Biologics License Application for the combination of ublituximab and umbralisib for the treatment of chronic lymphocytic leukemia has been completed for submission to the FDA.
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Clinical Benefit Demonstrated With Ublituximab Plus Ibrutinib in R/R CLL
March 15th 2021Patients with relapsed or refractory high-risk chronic lymphocytic leukemia achieved a statistically higher rate of overall response when the glycoengineered, type I anti-CD20 monoclonal antibody ublituximab was added to the Bruton’s tyrosine kinase inhibitor ibrutinib, according to results from the phase 3 GENUINE study.
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