Press Room

01.28.19

AbbVie Announces U.S. FDA Approval of IMBRUVICA® (ibrutinib) Plus Obinutuzumab (GAZYVA®) – First Chemotherapy-Free, Anti-CD20 Combination Regimen Approved for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) in Previously Untreated Patients

Pharmacyclics is an AbbVie company based in Silicon Valley, California developing and commercializing small-molecule medicines for the treatment of cancers and immune-mediated diseases for which there is a great unmet medical need.

We seek to discover innovative solutions to improve standards of care and strive to help our patients rediscover the Magic of Normal.
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2019

2018

IMBRUVICA® (ibrutinib) Combination Regimen Significantly Improved Survival Versus the Chemoimmunotherapy FCR (Fludarabine, Cyclophosphamide and Rituximab) in Previously Untreated and Younger Chronic Lymphocytic Leukemia (CLL) Patients; Late-Breaking Phase 3 Data at ASH 2018
IMBRUVICA® (ibrutinib) Phase 3 Combination Data with Obinutuzumab Finds Significant Improvement in Progression-Free Survival (PFS) Over Standard Chemoimmunotherapy of Chlorambucil Plus Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
IMBRUVICA® (ibrutinib) Data in Chronic Lymphocytic Leukemia (CLL) Show up to Seven Years of Progression-free Survival (PFS) in 80 Percent of Previously Untreated Patients, the Longest Follow-up for a Bruton's Tyrosine Kinase Inhibitor to Date
AbbVie Announces Supplemental New Drug Application Accepted for Priority Review by U.S. FDA for IMBRUVICA® (ibrutinib) in Combination with Obinutuzumab (GAZYVA®) for Previously Untreated Chronic Lymphocytic Leukemia (CLL)
AbbVie Announces IMBRUVICA® (ibrutinib) Plus Rituximab Approval by U.S. FDA as First Chemotherapy-Free Combination Treatment in Adults with Waldenström’s Macroglobulinemia, a Rare Type of Blood Cancer
AbbVie Provides Update on Phase 3 Study of Ibrutinib (IMBRUVICA®) in Blood Cancer Diffuse Large B-Cell Lymphoma (DLBCL) and Ongoing Ibrutinib Clinical Program
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
Phase 2 IMBRUVICA® (ibrutinib) Plus VENCLEXTA® (Venetoclax) Early Data Show High Rates of Responses in Patients with Previously-Untreated Chronic Lymphocytic Leukemia (CLL)
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
IMBRUVICA® (ibrutinib) Plus GAZYVA® (obinutuzumab) Phase 3 iLLUMINATE Trial for First-Line Therapy of Chronic Lymphocytic Leukemia (CLL) Patients Met Primary Endpoint
Important Update for Healthcare Professionals and Patients Regarding IMBRUVICA® (ibrutinib)
An Important Message for Patients and Healthcare Professionals Who Depend on IMBRUVICA® (ibrutinib)

2017

IMBRUVICA® (ibrutinib) Data Provides Insights into Its Potential Treatment Benefits for Previously Treated Chronic Graft-Versus-Host-Disease – A Serious, Possibly Life-Threatening Condition
IMBRUVICA® (ibrutinib) Data Provides Insights into Its Potential Treatment Benefits for Previously Treated Chronic Graft-Versus-Host-Disease – A Serious, Possibly Life-Threatening Condition
IMBRUVICA® (ibrutinib) Patient-Reported Outcomes Data Detail Long-term Improvement in Treatment Outcomes and Quality of Life Experience in Chronic Lymphocytic Leukemia (CLL) Patients
IMBRUVICA® (ibrutinib) Pooled Analysis Suggest Benefit in Progression-Free Survival (PFS) at 3.5 Years in Patients with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL)
IMBRUVICA® (ibrutinib) Plus Rituximab Phase 3 iNNOVATE Trial in Rare Waldenström's Macroglobulinemia Met Primary Endpoint
U.S. FDA Approves IMBRUVICA® (ibrutinib) as First Approved Treatment Specifically for Adults with Chronic Graft-Versus-Host-Disease (cGVHD) -- A Serious, Potentially Life-Threatening Condition -- After Failure of One or More Lines of Systemic Therapy
New Data Presented at ASCO 2017 Finds IMBRUVICA® (ibrutinib) May Offer a More Targeted Approach to Chronic Lymphocytic Leukemia (CLL) Treatment than Chemotherapy Agent Chlorambucil in Treatment-Naïve Patients
IMBRUVICA® (ibrutinib) Pooled Outcomes Data from Three Phase 3 Studies Suggest Potential Clinical Efficacy in Patients with High-Risk Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
AbbVie Announces Ibrutinib (IMBRUVICA®) Supplemental New Drug Application for Previously Treated Chronic Graft-Versus-Host-Disease (cGVHD) Accepted for Review by U.S. FDA
U.S. FDA Approves IMBRUVICA® (ibrutinib) as First Treatment Specifically Indicated for Relapsed/Refractory Marginal Zone Lymphoma (MZL) - a Rare Type of Non-Hodgkin's Lymphoma