Oncology

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.

NORTH CHICAGO, Ill., Jan. 28, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved the use of IMBRUVICA^® (ibrutinib) in combination with obinutuzumab (GAZYVA^®) for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The latest FDA approval expands the use of IMBRUVICA, which can already be administered as a single agent or in combination with bendamustine and rituximab (BR) for adult CLL/SLL patients.¹ IMBRUVICA is a once-daily, first-in-class Bruton's tyrosine kinase (BTK) inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.

NORTH CHICAGO, Ill., Jan. 18, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced an update on the Phase 3 RESOLVE trial (PCYC-1137) of ibrutinib (IMBRUVICA^®) in combination with chemotherapy agents nab-paclitaxel and gemcitabine versus placebo in combination with these chemotherapy agents in patients with metastatic pancreatic adenocarcinoma (cancer). Metastatic pancreatic cancer is an aggressive and difficult-to-treat solid tumor primarily treated with chemotherapy today. IMBRUVICA is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc. (Janssen). IMBRUVICA has been available in the U.S. since 2013 and is FDA-approved for use in five B-cell blood cancers, as well as in chronic graft-versus-host-disease for a total of nine FDA-approved indications.