AbbVie Announces Submission of Supplemental New Drug Application to US FDA for Venetoclax in Newly Diagnosed Acute Myeloid Leukemia Patients Ineligible for Intensive Chemotherapy

– Acute myeloid leukemia (AML) is one of the most aggressive cancers, with a very low survival rate and few options available for patients who are ineligible for intensive chemotherapy

AbbVie Provides Update on Phase 3 Study of Ibrutinib (IMBRUVICA®) in Blood Cancer Diffuse Large B-Cell Lymphoma (DLBCL) and Ongoing Ibrutinib Clinical Program

- The ibrutinib clinical program is designed to fully explore the potential of this first-in-class molecule as a single or combination therapy for multiple cancers and other diseases. Fourteen Phase 3 company-sponsored studies are ongoing.

IMBRUVICA® (ibrutinib) Supplemental New Drug Application Accepted for Review by U.S. FDA with Potential to Broaden Treatment Use as a Combination Treatment Option with Rituximab in Waldenström's Macroglobulinemia (WM), A Rare Form of Blood Cancer

NORTH CHICAGO, Ill., June 25, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental New Drug Application (sNDA) for IMBRUVICA® (ibrutinib) in combination with rituximab (RITUXAN®) as a new treatment option for Waldenström's macroglobulinemia (WM), a rare and incurable form of blood cancer.1 If approved, the sNDA would expand the prescribing information of IMBRUVICA in WM beyond its current approved use as a single agent for all lines of therapy to include combination use with rituximab. As a single-agent therapy, IMBRUVICA is the first and only FDA-approved treatment available for patients with WM. 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.

AbbVie Announces New Undetectable Minimal Residual Disease Data from Phase 3 Relapsed/Refractory Chronic Lymphocytic Leukemia MURANO Trial of Venetoclax in Combination with Rituximab at 23rd European Hematology Association Annual Congress

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 rituximab (VenR) in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). Of the 121 patients who achieved uMRD (meaning less than one CLL cell in 10,000 white blood cells were detectable using a standardized test2) at the end of combination therapy (EOCT), 83 percent (n=100) maintained uMRD and were progression-free for a median of 13.8 months (range, 5.6-23.0 months) thereafter. These results will be presented in an oral session on Saturday, June 16, at 11:45 a.m. CEST during the 23rd European Hematology Association (EHA) Annual Congress in Stockholm.1  Venetoclax is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

AbbVie Announces U.S. FDA Approval of VENCLEXTA® (venetoclax tablets) in Combination with Rituximab as a Fixed Duration Treatment for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Patients Who Have Received One Prior Therapy

NORTH CHICAGO, Ill., June 8, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has approved, under priority review, VENCLEXTA® (venetoclax tablets) in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.1

A Physician’s View: Facing the Challenges of Treating AML in Older Adults

Why are the odds stacked against the older population when it comes to this pervasive aggressor?

Phase 2 IMBRUVICA® (ibrutinib) Plus VENCLEXTA® (venetoclax) Early Data Show High Rates of Responses in Patients with Previously-Untreated Chronic Lymphocytic Leukemia (CLL)

NORTH CHICAGO, Ill., June 3, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive data from the Phase 2 CAPTIVATE (PCYC-1142) study evaluating IMBRUVICA® (ibrutinib) in combination with VENCLEXTA® (venetoclax) in previously-untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients. Early results of the combination oral regimen suggest promising activity in treatment-naïve CLL/SLL with 77 percent of the first 30 patients achieving responses with no detectable minimal residual disease (MRD) after six cycles of the combination therapy. MRD is determined by measuring the number of cancer cells remaining and helps confirm depth of remission. The first 14 CLL/SLL patients to complete the clinical trial combination therapy of 12 cycles (15 cycles of ibrutinib) achieved responses with no detectable MRD in approximately nine out of 10 patients, with 93 percent achieving MRD negativity when measuring in peripheral blood and 86 percent with MRD negativity when measuring in the bone marrow.1

Phase 3 IMBRUVICA® (ibrutinib) Data Suggest Improved Treatment Outcomes in Waldenström's Macroglobulinemia (WM), a Rare Form of Blood Cancer, in Combination with Rituximab versus Rituximab Alone

NORTH CHICAGO, Ill., June 1, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced findings from an interim analysis of the Phase 3 iNNOVATE (PCYC-1127) study evaluating IMBRUVICA® (ibrutinib) plus RITUXAN® (rituximab) in previously untreated and relapsed/refractory patients with Waldenström's macroglobulinemia (WM), a rare type of non-Hodgkin's lymphoma (NHL). At a median follow up of 26.5 months, the study successfully met its primary endpoint, demonstrating a significant improvement in progression-free survival (PFS) with ibrutinib plus rituximab compared to rituximab alone (30 month PFS rates were 82 percent versus 28 percent, respectively). Patients taking ibrutinib plus rituximab also experienced an 80 percent reduction in relative risk of disease progression or death than those only treated with rituximab (hazard ratio, 0.20; confidence interval: 0.11-0.38, P <0.0001). Additionally, the data found that the combination with ibrutinib provided reductions in infusion reactions associated with rituximab and immunoglobin M (IgM) flare.1

AbbVie to Present New Data from Several Investigational Studies of Venetoclax as Monotherapy or in Combination for the Management of a Number of Difficult-to-Treat Blood Cancers at 23rd European Hematology Association (EHA) Annual Congress

NORTH CHICAGO, Ill., May 31, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it will present data from clinical trials across multiple blood cancers evaluating venetoclax, a first-in-class oral B-cell lymphoma-2 (BCL-2) inhibitor, as monotherapy and in combination with other therapies at the 23rd European Hematology Association (EHA) Annual Congress, June 14-17, in Stockholm, Sweden. A total of 11 abstracts will be presented, including results of venetoclax in chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), multiple myeloma (MM) and acute lymphoblastic leukemia (ALL). Venetoclax is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

How We Got Here: AbbVie in Oncology

Our oncology story began with a focus on attacking an “unhittable” cancer target.