Press Room

11.08.19

AbbVie Submits Supplemental New Drug Application to U.S. FDA For IMBRUVICA® (ibrutinib) in Combination with Rituximab for the Treatment of Previously Untreated, Younger Adults with Chronic Lymphocytic Leukemia

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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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) Pooled Analysis Suggests Benefit in Progression-Free Survival (PFS) at 3.5 Years in Patients with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL)
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) 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
Long-Term IMBRUVICA® Efficacy and Safety Data at ASCO 2017 Show Sustained Survival Rates in Up to Four Years in Previously-Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Patients, Including Those with High-Risk Disease
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

2016

Late-Breaking Ibrutinib (IMBRUVICA®) Data Show Complete or Partial Response in Two-Thirds of Patients with Chronic Graft-Versus-Host-Disease, a Frequent and Potentially Life-Threatening Complication of Stem Cell Transplant
New Phase 2 Data Show Nearly Half of Patients with Relapsed/Refractory Marginal Zone Lymphoma (MZL) Respond to Treatment with Ibrutinib (IMBRUVICA®)
Favorable Response Rates Suggest Promise of Ibrutinib (IMBRUVICA®) Combination Therapy in Two Common Types of Non-Hodgkin's Lymphoma
IMBRUVICA® (ibrutinib) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma 5-Year Analysis and Long-Term RESONATE-2 Follow-up Data at ASH 2016 Show Lasting Efficacy
AbbVie Announces Submission of a Supplemental New Drug Application for Ibrutinib (IMBRUVICA®) for Treatment of Marginal Zone Lymphoma
AbbVie Announces Fourth Breakthrough Therapy Designation Granted by the U.S. Food and Drug Administration (FDA) for Ibrutinib (IMBRUVICA®) for Chronic Graft-Versus-Host-Disease (cGVHD), a Rare Condition with Limited Treatment Options
AbbVie Builds Upon Robust Body of IMBRUVICA® (ibrutinib) Data with Phase 3 Longer-Term Studies in Patients with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting
European Commission Approves IMBRUVICA® (ibrutinib) for First-Line Treatment of Patients with Chronic Lymphocytic Leukemia
U.S. FDA Expands IMBRUVICA® (ibrutinib) Label to Include Overall Survival Data in Previously Untreated Chronic Lymphocytic Leukemia (CLL) and New Indication for Small Lymphocytic Lymphoma (SLL) Patients
European Medicines Agency Issues Positive Opinion for the Use of IMBRUVICA® (ibrutinib) as a First-Line Treatment for Chronic Lymphocytic Leukemia Patients
IMBRUVICA® (ibrutinib) Approved by U.S. FDA for the First-line Treatment of Chronic Lymphocytic Leukemia