Tag Archives: Venetoclax

November, 2018

21 November
FDA Grants Accelerated Approval to Venclexta for Newly-Diagnosed Acute Myeloid Leukemia or Patients Ineligible for Intensive Induction Chemo

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 granted accelerated approval to Venclexta® (venetoclax), in combination with a hypomethylating agent (azacitidine or decitabine), or low-dose cytarabine (LDAC), for the treatment of people …
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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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12 July
AbbVie Submits sNDA to FDA for Venetoclax in Newly Diagnosed AML Patients Ineligible for Intensive Chemotherapy

NORTH CHICAGO, Ill., July 12, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for venetoclax in combination with a hypomethylating agent (HMA) or in combination with low-dose cytarabine (LDAC) for the treatment …
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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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19 September
AbbVie Announces Positive Results from Late-Stage Relapsed/Refractory Chronic Lymphocytic Leukemia Study

NORTH CHICAGO, Ill., Sept. 18, 2017 /PRNewswire/ — AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that the Phase 3 MURANO study of VENCLEXTA™/VENCLYXTO™ (Venetoclax) Tablets in combination with Rituxan® (rituximab) met its primary endpoint. Results showed that VENCLEXTA/VENCLYXTO in combination with Rituxan prolonged progression-free survival (PFS) in patients with relapsed/refractory (R/R) chronic …
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28 July
FDA Grants Breakthrough Therapy Designation for Roche’s Venclexta in Acute Myeloid Leukemia

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Venclexta® (venetoclax) in combination with low dose cytarabine (LDAC) for elderly patients with previously untreated AML who are ineligible for intensive chemotherapy. FDA breakthrough therapy designation is intended …
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20 January
FDA Grants Breakthrough Therapy Designation to AbbVie’s Chronic Lymphocytic Leukemia Drug

NORTH CHICAGO, Ill., Jan. 20, 2016 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for venetoclax in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL). Venetoclax is an inhibitor …
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