Tag Archives: ibrutinib

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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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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27 August
FDA Approves Imbruvica Plus Rituximab for Treatment of Adults with Waldenström’s Macroglobulinemia

NORTH CHICAGO, Ill., Aug. 27, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved IMBRUVICA® (ibrutinib) plus rituximab (RITUXAN®) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM), a rare and incurable type of non-Hodgkin’s lymphoma (NHL). With this approval, the …
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16 August
ArQule Announces Publication of Preclinical Data for ARQ 531, a Reversible Inhibitor of Both Wild Type and Mutant BTK

BURLINGTON, Mass.–(BUSINESS WIRE)–ArQule, Inc. (Nasdaq:ARQL), today announced the publication of preclinical study data for ARQ 531, the Company’s rationally-designed, reversible inhibitor of both wild type and C481S-mutant Bruton’s tyrosine kinase (BTK). The studies, published in Cancer Discovery, were conducted in collaboration with researchers at The Ohio State University. Data from …
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11 July
Imbruvica Fails to Meet Primary Endpoint in Phase 3 Trial in Newly Diagnosed Non-Germinal Center B Cell Subtype of DLBCL

RARITAN, N.J., July 11, 2018 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today topline results from the Phase 3 PHOENIX trial evaluating the investigational use of IMBRUVICA® (ibrutinib) in the treatment of newly diagnosed non-Germinal Center B cell (non-GCB) subtype of diffuse large B-cell lymphoma (DLBCL), …
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7 December
Imbruvica in Combination with Rituximab Meets Primary Endpoint in Phase 3 Waldenström’s Macroglobulinemia Study

RARITAN, N.J., Dec. 5, 2017 /PRNewswire/ — Janssen Research & Development, LLC (Janssen) announced that the Phase 3 iNNOVATE (PCYC-1127) study evaluating IMBRUVICA® (ibrutinib) in combination with rituximab (RITUXAN®) in relapsed/refractory and treatment-naïve patients with Waldenström’s macroglobulinemia (WM) successfully met its primary endpoint of progression-free survival (PFS). An Independent Data …
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3 August
FDA Approves Imbruvica as First and Only Approved Therapy for Patients with Chronic Graft-Versus-Host-Disease

HORSHAM, Pa., Aug. 2, 2017 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) for the treatment of adult patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy.1 IMBRUVICA is the first and only FDA-approved medication for adult patients with …
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5 April
FDA Accepts AbbVie and Janssen’s sNDA for Imbruvica for Treatment of Chronic Graft-Versus-Host-Disease

NORTH CHICAGO, Ill., April 4, 2017 – AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced a supplemental New Drug Application (sNDA) was accepted for review by the U.S. Food and Drug Administration (FDA) for ibrutinib (IMBRUVICA®) in chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic …
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6 March
TG Therapeutics’ Chronic Lymphocytic Leukemia Drug Demonstrates Positive Results in Late-Stage Study

NEW YORK, March 06, 2017 (GLOBE NEWSWIRE) — TG Therapeutics (NASDAQ:TGTX) today announced positive topline results from its Phase 3 GENUINE clinical trial of TG-1101 (ublituximab) plus ibrutinib in patients with previously treated high risk Chronic Lymphocytic Leukemia (CLL). For the study, high risk was defined as having any one …
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7 December
AbbVie’s Imbruvica Benefits Treatment-Resistant GVHD Patients in Mid-Stage Study

NORTH CHICAGO, Ill., Dec. 6, 2016 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced positive results from a Phase 2 study (PCYC-1129) evaluating ibrutinib (IMBRUVICA®) in patients with chronic graft-versus-host-disease (cGVHD), a serious and debilitating potential consequence of stem cell or bone marrow transplant,1 who failed prior systemic …
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