NORTH CHICAGO, Ill., Dec. 8, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today presented long-term data from a post-hoc analysis, further supporting the sustained clinical benefit of fixed duration treatment with VENCLEXTA®/VENCLYXTO® (venetoclax) in combination with rituximab (VenR) in patients with relapsed or refractory chronic lymphocytic leukemia (R/R CLL). The updated data from the Phase 3 MURANO trial four-year analysis (median follow-up of 48 months with all patients off VENCLEXTA/VENCLYXTO treatment for a median of 22 months) showed that patients with R/R CLL who completed the chemotherapy-free, two-year fixed duration course of VENCLEXTA/VENCLYXTO treatment combination maintained progression-free survival (PFS) and overall survival (OS). Patients who completed treatment with the VENCLEXTA/VENCLYXTO combination also achieved higher rates of minimal residual disease (MRD)-negativity and complete remissions compared to those treated with a standard of care, bendamustine plus rituximab (BR).1 The full results were presented today at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition (abstract #355).
NORTH CHICAGO, Ill., Nov. 21, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that more than 40 abstracts, including 18 oral presentations, will be presented during the upcoming American Society of Hematology (ASH) Annual Meeting & Exposition, December 7-10, in Orlando, FL. New data include presentations on Ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®) among others.
NORTH CHICAGO, Ill., Aug. 29, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research based global biopharmaceutical company, today announced that MERU, a Phase 3 trial evaluating Rova-T as a first-line maintenance therapy for advanced small-cell lung cancer (SCLC), demonstrated no survival benefit at a pre-planned interim analysis for patients receiving Rova-T as compared with placebo. The overall safety profile was generally consistent with that observed in previous studies. The MERU trial is being closed, and the Rova-T research and development program has been terminated. AbbVie will move forward prioritizing other development programs within its oncology pipeline.
NORTH CHICAGO, Ill., June 24, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold placed on CANOVA (M13-494), a Phase 3 trial evaluating venetoclax (VENCLEXTA® OR VENCLYXTO®) for the investigational treatment of relapsed/refractory multiple myeloma. The CANOVA trial evaluates venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone in patients with relapsed/refractory multiple myeloma positive for the translocation (11;14) abnormality. The t(11;14) genetic biomarker is among the most common and routinely tested genetic abnormalities in patients with multiple myeloma.1
- Phase 3 data from CLL14 study were highlighted in an oral presentation (abstract #7502) today at ASCO and published in the New England Journal of Medicine
NORTH CHICAGO, Ill., May 30, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it will present more than 40 data updates across its oncology portfolio during the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting on May 31-June 4, in Chicago, and the European Hematology Association (EHA) Annual Congress on June 13-16, in Amsterdam. The data presentations will span the company's investigational and approved oncology portfolio medicines in more than 15 different blood and solid tumor cancers.
NORTH CHICAGO, Ill., May 15, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved VENCLEXTA® (venetoclax) in combination with obinutuzumab (GAZYVA®) for previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1 The FDA granted Breakthrough Therapy designation for this combination therapy, and early submission of the data was provided under the Real-Time Oncology Review (RTOR) pilot program, which led to approval in just over two months, following submission of the complete application.
NORTH CHICAGO, Ill., March 19, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on all clinical trials evaluating venetoclax (VENCLEXTA®/VENCLYXTO®) for the investigational treatment of multiple myeloma. The partial clinical hold follows a review of data from the ongoing Phase 3 BELLINI trial (M14-031), a study in relapsed/refractory multiple myeloma, in which a higher proportion of deaths was observed in the venetoclax arm compared to the control arm of the trial. As a result of this action, no new patients should be enrolled in any studies of venetoclax for multiple myeloma until a further analysis of the data is completed. Patients who are currently enrolled in studies and receiving benefit from the therapy may continue with treatment, after consultation with their physician.
NORTH CHICAGO, Ill., March 7, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) granted a fifth Breakthrough Therapy Designation (BTD) to venetoclax, for use in combination with obinutuzumab as a fixed duration investigational combination, for untreated adult patients with chronic lymphocytic leukemia (CLL). According to the FDA, this designation is intended to expedite the review of therapies for serious or life-threatening conditions. The designation coincides with the completion of the supplemental New Drug Application (sNDA) submission to the FDA for approval in previously-untreated CLL patients.
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