Tag Archives: Chronic Lymphocytic Leukemia

December, 2018

5 December
Imbruvica Combination Regimen Significantly Improved Survival in Phase 3 Trial in Previously Untreated and Younger CLL Patients

NORTH CHICAGO, Ill., Dec. 4, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today shared results from the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), National Cancer Institute (NCI)-sponsored, Phase 3 study (E1912) evaluating IMBRUVICA® (ibrutinib) plus rituximab versus the current National Comprehensive Cancer Network (NCCN) guidelines Category 1 treatment of fludarabine, cyclophosphamide …
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1 November
AbbVie’s Venetoclax Demonstrates Positive Results in Phase 3 Study as First-Line Therapy in Patients with Chronic Lymphocytic Leukemia

NORTH CHICAGO, Ill., Oct. 31, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive results from CLL14, a Phase 3, randomized clinical trial evaluating venetoclax plus obinutuzumab versus obinutuzumab plus chlorambucil, a standard of care, in patients with chronic lymphocytic leukemia (CLL) and coexisting medical conditions who …
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17 October
FDA Grants Priority Review to AbbVie’s sNDA for Imbruvica in Combination with Gazyva for Previously Untreated Chronic Lymphocytic Leukemia

NORTH CHICAGO, Ill., Oct. 17, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Priority Review for IMBRUVICA® (ibrutinib) in combination with obinutuzumab (GAZYVA®) in previously untreated adult patients with chronic lymphocytic leukemia or …
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12 September
FDA Expands Label of AbbVie’s Venclexta to Include Minimal Residual Disease Negativity Data

NORTH CHICAGO, Ill., Sept. 11, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has expanded the label for VENCLEXTA® (venetoclax tablets) in combination with rituximab to include information about patients with previously-treated chronic lymphocytic leukemia (CLL) who achieved minimal residual disease (MRD)-negativity …
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15 June
AbbVie Announces New Undetectable Minimal Residual Disease Data from Phase 3 Chronic Lymphocytic Leukemia Trial

NORTH CHICAGO, Ill., June 15, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the presentation of investigational data from a new analysis of undetectable minimal residual disease (uMRD) rates from the pivotal Phase 3 MURANO trial of venetoclax, a first-in-class oral B-cell lymphoma-2 (BCL-2) inhibitor, in combination with …
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11 June
FDA Approves Venclexta Plus Rituxan for People with Previously Treated Chronic Lymphocytic Leukemia

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Venclexta® (venetoclax) in combination with Rituxan®(rituximab) for the treatment of people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or …
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24 May
Imbruvica Plus Gazyva Improves Progression-Free Survival in Phase 3 Study in CLL/SLL Patients

NORTH CHICAGO, Ill., May 24, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the Phase 3 iLLUMINATE (PCYC-1130) trial met its primary endpoint of improvement in progression-free survival (PFS). The study evaluated IMBRUVICA® (ibrutinib) in combination with GAZYVA® (obinutuzumab) in previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) …
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9 April
FDA Accepts NDA and Grants Priority Review to Verastem’s Duvelisib

BOSTON–(BUSINESS WIRE)–Verastem, Inc. (NASDAQ:VSTM), a biopharmaceutical company focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its New Drug Application (NDA) for its lead product …
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13 December
Venclexta Plus Rituxan Reduces the Risk of Disease Progression or Death by 83% Compared to Standard of Care Regimen in Late-Stage CLL Study

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the first results from the pivotal Phase III MURANO study evaluating Venclexta™ (venetoclax) plus Rituxan® (rituximab) compared to bendamustine plus Rituxan (BR) for the treatment of people with relapsed or refractory chronic lymphocytic …
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11 December
AstraZeneca’s Calquence Shows Potential in Clinical Trials in Patients with Chronic Lymphocytic Leukemia

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Acerta Pharma, its hematology research and development center of excellence, today presented results from the Phase Ib/II ACE-CL-003 clinical trial (Abstract #432) and updated results from the Phase I/II ACE-CL-001 (Abstract #498) clinical trial that are evaluating acalabrutinib alone and in combination for the treatment of …
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