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
New CLL Survival Milestones Reached
November 8th 2018Richard Furman, MD, discusses how survival times for patients with chronic lymphocytic leukemia have increased dramatically in the past decade, thanks to an ever-expanding armamentarium of novel agents and more patients now being diagnosed earlier.
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A Look Back at FDA News from October 2018
November 1st 2018A look back at all the FDA news that happened in the month of October 2018, including several new FDA approvals, priority reviews, a breakthrough therapy designation, and more, in a variety of cancer types.<br />
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PFS Improvement With Venetoclax Plus Obinutuzumab in Frontline CLL
November 1st 2018Treatment-naïve patients with chronic lymphocytic leukemia who had comorbidities saw a reduction in the risk of disease progression or death after treatment with venetoclax combined with obinutuzumab versus obinutuzumab plus chlorambucil.
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Ibrutinib and Obinutuzumab Combo Granted Priority Review by FDA For Frontline CLL
October 17th 2018A supplemental new drug application for ibrutinib (Imbruvica) has been granted a priority review by the FDA for use in combination with obinutuzumab (Gazyva) as a frontline treatment for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
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Natural Killer Cells Could Bypass Limitations of CAR T Cells in CLL, Expert Says
September 27th 2018In an interview with <em>Targeted Oncology</em>, Katy Rezvani, MD, discussed the potential she sees with CAR NK cells. She also highlighted some of the challenges with both CAR T-cell therapy in patients with CLL, as well as challenges to overcome with CAR NK cells in this patient population.
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Duvelisib Granted FDA Approval for CLL and Follicular Lymphoma
September 25th 2018Duvelisib (Copiktra) has been approved by the FDA for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma or relapsed/refractory follicular lymphoma. Both indications are for the treatment of patients who have received at least 2 prior therapies.
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EU Panel Supports Approval of Venetoclax/Rituximab Combo in Relapsed/Refractory CLL
September 24th 2018Based on data from the phase III MURANO trial, the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of venetoclax for patients with chronic lymphocytic leukemia who have received at least 1 previous therapy. AbbVie, a co-developer of venetoclax with Roche, announced the CHMP’s decision in a news release.
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Venetoclax CLL Label Updated by FDA to Include MRD Data
September 13th 2018Minimal residual disease data from the phase III MURANO trial has been added to the label for venetoclax (Venclexta) by the FDA for its approved use in combination with rituximab (Rituxan) for previously-treated patients with chronic lymphocytic leukemia.
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Lead-In Treatment to Reduce Tumor Lysis Syndrome Risk in CLL
August 21st 2018Kerry Rogers, MD, assistant professor at The Ohio State University Comprehensive Cancer Center, discusses a short-term treatment strategy for reducing tumor burden and the risk for tumor lysis syndrome in patients with chronic lymphocytic leukemia.
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Complications With CAR T Cells in Chronic Lymphocytic Leukemia
July 31st 2018Susan M. O'Brien, MD, associate director for clinical sciences at UC Irvine Health, shares her insights on why CAR T cells are not as successful in chronic lymphocytic leukemia as compared to lymphoma or acute lymphocytic leukemia. She also discusses what she believes must change in order for this therapy to move up in the treatment landscape for CLL.
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Navigating Treatment Options for Patients With Relapsed/Refractory CLL
July 17th 2018Danielle M. Brander, MD, assistant professor of medicine at Duke University School of Medicine and member of the Duke Cancer Institute, discusses a major challenge in the field of chronic lymphocytic leukemia. She says the biggest challenge to overcome in the treatment of patients with CLL is navigating areas where research is not yet mature.
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As New Treatments Emerge in CLL, Comparative Data Still Needed
July 16th 2018While the approval of new agents represents a great step forward in the treatment of chronic lymphocytic leukemia (CLL), physicians are now challenged with how to best utilize these new treatment options, according to a presentation by Anthony Mato, MD, MSCE, at the 2nd Annual Live Medical Crossfire: Hematologic Malignancies.
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Obinutuzumab Appears Safe, Effective in Relapsed/Refractory CLL
July 12th 2018An updated analysis of obinutuzumab alone or in combination with chemotherapy for patients with treatment-naïve or relapsed/refractory chronic lymphocytic leukemia detected no new safety signals. Investigators in the phase IIIb GREEN trial also found overall response rates greater than 80% at 3 months post-treatment in some patients.
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Phase III Findings Support Obinutuzumab/Chlorambucil as Frontline CLL Option
June 22nd 2018According to long-term follow-up data from the phase III CLL11 study, treatment with obinutuzumab combined with chlorambucil reduced the risk of death by 24% versus rituximab plus chlorambucil in treatment-naïve patients with chronic lymphocytic leukemia with comorbidities. These findings were presented at the 2018 European Hematology Association Congress.
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Addressing Challenges for Patients With Relapsed CLL
June 20th 2018Neil E. Kay, MD, a professor of medicine at the Mayo Clinic, discusses the challenges that arise when treating a patient with relapsed chronic lymphocytic leukemia (CLL). Most times, responses in this setting are short lived.
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Duvelisib Plus FCR Demonstrates Promise as Frontline Treatment for Younger Patients With CLL
June 19th 2018Matthew S. Davids, MD, MMSc, discusses the findings with duvelisib plus fludarabine-cyclophosphamide-rituximab as a frontline therapy for younger patients with CLL, as well as the potential future for this agent in the treatment of patients with CLL.
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Venetoclax Granted Full FDA Approval for CLL, Regardless of 17p Deletion
June 8th 2018Based on data from the phase III MURANO trial, venetoclax has been granted a regular approval by the FDA for the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, with or without 17p deletion, who has received at least 1 prior therapy.
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