Combo bests standard care in younger CLL patients

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2018 ASH Annual Meeting
©ASH/Scott Morgan 2018
In a phase 3 trial, ibrutinib plus rituximab (IR) improved survival when compared with standard chemoimmunotherapy in patients younger than 70 with untreated chronic lymphocytic leukemia (CLL). Patients who received IR had superior progression-free survival (PFS) and overall survival compared to patients who received fludarabine, cyclophosphamide, and rituximab... [Read Article]
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Sandoz won’t seek U.S. approval for rituximab biosimilar

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Vials and a syringe
Sandoz has decided not to pursue U.S. approval for its rituximab product (GP2013), a proposed biosimiliar of Rituxan/Mabthera. GP2013 (Rixathon, Riximyo) is already approved outside the U.S. Sandoz was seeking U.S. approval of GP2013 for all the same indications as the reference product—B-cell non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis,... [Read Article]
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sNDA gets priority review for CLL/SLL

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Ibrutinib (Imbruvica)
Photo courtesy of Janssen
The U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for ibrutinib (Imbruvica®). With this sNDA, Pharmacyclics LLC (an AbbVie company) and Janssen Biotech, Inc., are seeking approval for ibrutinib in combination with obinutuzumab (Gazyva®) in previously untreated adults with... [Read Article]
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Variant not associated with CLL, AIHA, or ITP in certain patients

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DNA helix
Image by Spencer Phillips
New research suggests there is no association between the PTPN22 R620W polymorphism and chronic lymphocytic leukemia (CLL) or autoimmune hematologic disorders in patients from the Republic of Macedonia. Past studies have shown an association between the PTPN22 R620W variant and both CLL and autoimmune diseases in patients from... [Read Article]
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Duvelisib bests ofatumumab as monotherapy for treatment of CLL/SLL

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Ian W. Flinn, MD, PhD
Photo from Sarah Cannon
Final analysis of the phase 3 DUO trial has shown monotherapy with oral duvelisib results in a statistically significant improvement in progression-free survival (PFS) and overall response rate (ORR) compared to monotherapy with ofatumumab for patients with relapsed or refractory chronic lymphocytic leukemia/small lympchocytic lymphoma (CLL/SLL).... [Read Article]
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FDA approves duvelisib for CLL/SLL and FL

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Micrograph showing CLL
The U.S. Food and Drug Administration (FDA) has approved duvelisib (Copiktra™), a dual PI3K delta/gamma inhibitor, for two indications. Duvelisib has full FDA approval to treat adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have received at least two prior therapies. Duvelisib also has accelerated approval to... [Read Article]
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CHMP supports new indication for venetoclax

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U.S. version of venetoclax
Photo courtesy of Abbvie
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission (EC) approve a new indication for venetoclax (Venclyxto®). AbbVie is seeking EC approval for venetoclax in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic... [Read Article]
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Stress linked to disease markers in CLL

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Micrograph showing CLL
New research has linked stress levels to markers of progressive disease in patients with chronic lymphocytic leukemia (CLL). Researchers found that CLL patients who reported more stress also had higher absolute lymphocyte counts and elevated levels of three other markers of more advanced disease—tumor necrosis factor-α (TNFα), interleukin 16 (IL-16), and chemokine... [Read Article]
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MRD data added to venetoclax label

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First month’s supply of
venetoclax (Venclexta)
Photo courtesy of Abbvie
The U.S. Food and Drug Administration (FDA) has expanded the label for venetoclax tablets (Venclexta®) to include data on minimal residual disease (MRD). The drug’s prescribing information now includes details on MRD negativity in previously treated patients with chronic lymphocytic leukemia (CLL) who received venetoclax... [Read Article]
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Ibrutinib maintains efficacy over time

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Micrograph showing CLL
Extended follow-up of the RESONATE-2 trial showed that first-line ibrutinib sustained efficacy in elderly patients with chronic lymphocytic leukemia (CLL). Patients who received ibrutinib had a long-term progression-free survival benefit over those who received chlorambucil. The depth of response to ibrutinib improved over time, which meant there was a substantial increase in... [Read Article]
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