Tag Archives: gazyva

October, 2018

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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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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17 November
FDA Approves Genentech’s Gazyva for Previously Untreated Advanced Follicular Lymphoma

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) approved Gazyva® (obinutuzumab) in combination with chemotherapy, followed by Gazyva alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II …
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28 August
FDA Grants Priority Review for Genentech’s Gazyva in Previously Untreated Follicular Lymphoma

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 accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Gazyva® (obinutuzumab) in combination with chemotherapy followed by Gazyva alone for …
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18 July
Roche’s Blood Cancer Drug Fails to Meet Primary Endpoint in Late-Stage Trial

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III GOYA study evaluating Gazyva®/Gazyvaro® (obinutuzumab) plus CHOP chemotherapy (G-CHOP) in people with previously untreated diffuse large B-cell lymphoma (DLBCL) did not meet its primary endpoint of significantly reducing the risk of disease worsening or death (progression-free survival; PFS) …
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4 February
Roche’s Gazyva Succeeds in its Late-Stage Trial in Non-Hodgkin’s Lymphoma

Roche announced that it has ended its late-stage study evaluating its leukemia drug Gazyva earlier than expected following positive results. The company announced positive results from the Phase III GADOLIN study, which evaluated treatment options for patients with indolent non-Hodgkin’s lymphoma (NHL) who are refractory to MabThera/Rituxan (rituximab) treatment. After …
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