Drugs / Ibrutinib
Ibrutinib
also known as
PCI-32765 · Imbruvica · JNJ-54179060 · CRA-032765 · IBR · Ibrutinib (IMBRUVICA) · PC-32765 · PCI-32765-00
Small molecule targets BTK, ITK via inhibition
Regulatory milestones approvals, filings & regulatory actions · 15 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (13) | US (FDA) | IMBRUVICA | — | 2014-07-28 – 2023-05-18 | fda.gov ↗ |
| Approved | EU (EMA) | Imbruvica | — | 2014-10-21 | europa.eu ↗ |
| Approved | US (FDA) | IMBRUVICA | — | 2013-11-13 | fda.gov ↗ |
Trials 304 · started per year
today
US approved 2013
EU approved 2014
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Also used as a comparator or background therapy in 48 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT03219047 Background | Dec 2018 → Jul 2023 | mantle cell lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 0 | NCT03295240 Background | Sep 2017 → Jan 2024 | mantle cell lymphoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 110 trials | ||||||
| Phase 1 | NCT04739813 Background | Jul 2021 → May 2026 overdue | Burkitt lymphoma, diffuse large B-cell lymphoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04043845 Background | Feb 2020 | B-cell chronic lymphocytic leukemia, Waldenstrom macroglobulinemia, mantle cell lymphoma, marginal zone lymphoma | Dana-Farber Cancer Institute | Withdrawn | No outcome recorded |
| Phase 1 | NCT03424122 Background | Jul 2018 → Jun 2022 | B-cell non-Hodgkin lymphoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT03400176 Background | Apr 2018 → Sep 2023 | B-cell chronic lymphocytic leukemia | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT03225716 Background | Oct 2017 → Dec 2022 | Waldenstrom macroglobulinemia | Dana-Farber Cancer Institute | Terminated | No outcome recorded |
| Phase 1 | NCT03136497 Background | Sep 2017 → Nov 2020 | diffuse large B-cell lymphoma | Hackensack Meridian Health | Terminated | No outcome recorded |
| Phase 1 | NCT02973399 Background | Feb 2017 → Dec 2018 | cancer | Esanex Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT02914327 Background | Feb 2017 → Jul 2018 | cancer | Esanex Inc. | Withdrawn | No outcome recorded |
| Phase 1 | NCT02759016 Background | Jun 2016 → Jun 2019 | B-cell chronic lymphocytic leukemia | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01644253 Background | Sep 2012 → Feb 2020 | B-cell chronic lymphocytic leukemia, peripheral T-cell lymphoma, not otherwise specified | Aptevo Therapeutics | Terminated | No outcome recorded |
| Phase 1/210 trials | ||||||
| Phase 1/2 | NCT07052695 Background | Nov 2025 → Dec 2028 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Inhye Ahn | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04446962 Comparator | Oct 2020 → Feb 2035 expected | central nervous system non-hodgkin lymphoma, diffuse large B-cell lymphoma | Institut Curie | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03960840 Background | Jun 2019 → Jun 2027 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma, diffuse large B-cell lymphoma, large B-cell lymphoma | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03572634 Background | Jun 2019 → Jan 2020 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Sumitomo Pharma America, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT03223610 Background | Feb 2018 → Dec 2026 expected | Burkitt lymphoma, diffuse large B-cell lymphoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03088878 Comparator | Jan 2018 → Sep 2024 | chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, marginal zone lymphoma | Oncternal Therapeutics, Inc | Completed | No outcome recorded |
| Phase 1/2 | NCT02912754 Background | Mar 2017 → Dec 2018 | B-cell chronic lymphocytic leukemia | Sunnybrook Health Sciences Centre | Unknown | No outcome recorded |
| Phase 1/2 | NCT02760485 Background | Dec 2016 → Jun 2022 | large B-cell lymphoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 1/2 | NCT02927964 Background | Nov 2016 → May 2023 | follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma | Robert Lowsky | Completed | No outcome recorded |
| Phase 1/2 | NCT02557516 Background | Nov 2015 → Oct 2018 | B-cell chronic lymphocytic leukemia | Innate Pharma | Terminated | No outcome recorded |
| Phase 212 trials | ||||||
| Phase 2 | NCT07350850 Comparator | Dec 2025 → Dec 2028 expected | primary central nervous system lymphoma | Tongji Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06958705 Background | Dec 2025 → Dec 2027 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT06520098 Background | Oct 2025 → Jun 2030 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 2 | NCT06524375 Background | Aug 2024 → Oct 2026 expected | B-cell chronic lymphocytic leukemia | Genentech, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04840602 Comparator | Jan 2022 → Mar 2028 expected | Waldenstrom macroglobulinemia | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT04685915 Background | Feb 2021 → Mar 2023 | B-cell chronic lymphocytic leukemia | Inhye Ahn | Withdrawn | No outcome recorded |
| Phase 2 | NCT04209621 Background | Jul 2020 → Jan 2021 | chronic lymphocytic leukemia/small lymphocytic lymphoma | National Heart, Lung, and Blood Institute (NHLBI) | Terminated | No outcome recorded |
| Phase 2 | NCT03679624 Background | Jul → Sep 2020 | Waldenstrom macroglobulinemia | Weill Medical College of Cornell University | Terminated | No outcome recorded |
| Phase 2 | NCT04016805 Background | Aug 2019 → May 2022 | chronic lymphocytic leukemia/small lymphocytic lymphoma | TG Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT03121534 Background | Jun 2017 → Feb 2022 | Richter transformation, hematopoietic and lymphoid system neoplasm | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT03128879 Background | Jun 2017 → May 2027 expected | B-cell chronic lymphocytic leukemia | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT02451111 Comparator | Nov 2015 → Dec 2022 | follicular lymphoma | Swiss Cancer Institute | Terminated | No outcome recorded |
| Phase 314 trials | ||||||
| Phase 3 | NCT07377578 Comparator | Feb 2026 → May 2031 expected | mantle cell lymphoma | Guangzhou Lupeng Pharmaceutical Company LTD. | Recruiting | No outcome recorded |
| Phase 3 | NCT06821542 Background | Jun 2025 → May 2028 expected | chronic graft versus host disease | Incyte Corporation | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06136559 Comparator | Dec 2023 → Sep 2032 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT05431179 Background | Mar 2023 → Nov 2026 | immunoproliferative disorder, lymphatic system disorder, lymphoproliferative syndrome, mantle cell lymphoma | Oncternal Therapeutics, Inc | Withdrawn | No outcome recorded |
| Phase 3 | NCT05254743 Comparator | Jul 2022 → Oct 2027 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Loxo Oncology, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT04662255 Comparator | Apr 2021 → Jan 2027 expected | mantle cell lymphoma | Loxo Oncology, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03570892 Comparator | May 2019 → May 2021 | non-Hodgkin lymphoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03734016 Comparator | Nov 2018 → Aug 2022 | chronic lymphocytic leukemia/small lymphocytic lymphoma | BeiGene | Completed | No outcome recorded |
| Phase 3 | NCT03112603 Comparator | Jun 2017 → May 2020 | chronic graft versus host disease | Incyte Corporation | Completed | No outcome recorded |
| Phase 3 | NCT02757040 Comparator | Dec 2016 → Dec 2017 | B-cell chronic lymphocytic leukemia | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT02735876 Comparator | May 2016 → Jun 2020 | mantle cell lymphoma | Acerta Pharma BV | Withdrawn | No outcome recorded |
| Phase 3 | NCT02477696 Comparator | Jul 2015 → Sep 2020 overdue | B-cell chronic lymphocytic leukemia | Acerta Pharma BV | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02436668 Comparator | May 2015 → Oct 2018 | pancreatic adenocarcinoma | Pharmacyclics LLC. | Completed | No outcome recorded |
| Phase 3 | NCT02863718 Comparator | Apr 2014 → Mar 2019 | B-cell chronic lymphocytic leukemia | German CLL Study Group | Completed | No outcome recorded |
Press releases naming this drug 61 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-04-06 | AbbVie | Update on IMBRUVICA® (ibrutinib) U.S. Accelerated Approvals for Mantle Cell Lymphoma and Marginal Zone Lymphoma Indications abbvie.com ↗ |
| 2022-12-10 | AbbVie | AbbVie Presents Data at the 64th American Society of Hematology (ASH) Annual Meeting Adds to Robust IMBRUVICA® (ibrutinib) Science abbvie.com ↗ |
| 2022-08-24 | AbbVie | Children with Chronic Graft Versus Host Disease (cGVHD) May Now Be Prescribed IMBRUVICA® (ibrutinib) abbvie.com ↗ |
| 2022-02-28 | AbbVie | AbbVie Seeks New Indication for IMBRUVICA® (ibrutinib) in Pediatric Patients with Chronic Graft Versus Host Disease (cGVHD) abbvie.com ↗ |
| 2021-06-12 | AbbVie | IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study abbvie.com ↗ |
| 2021-06-07 | AbbVie | CAPTIVATE Study Shows an IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Chemotherapy-Free Combination Has Potential to Provide Remission After Fixed-Duration Treatment for Chronic Lymphocytic Leukemia (CLL) abbvie.com ↗ |
| 2021-06-04 | AbbVie | Results from IMBRUVICA® (ibrutinib) RESONATE-2 Study Provide Up to Seven Years of Progression-Free and Overall Survival Data in First-Line Chronic Lymphocytic Leukemia (CLL) abbvie.com ↗ |
| 2020-12-23 | AbbVie | IMBRUVICA® (ibrutinib) U.S. Prescribing Information Updated to Include Long-Term Data for Waldenström's Macroglobulinemia (WM) abbvie.com ↗ |
| 2020-12-06 | AbbVie | Combined Data from Multiple Phase 3 Studies of IMBRUVICA® (ibrutinib) Show Efficacy and Safety in High-Risk, Previously Untreated Chronic Lymphocytic Leukemia (CLL) and Real-World Data Indicating Low Biomarker Testing Rates for These Patients abbvie.com ↗ |
| 2020-12-05 | AbbVie | IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows High Rates of Disease-Free Survival One Year Post-Treatment in Previously Untreated Patients with Chronic Lymphocytic Leukemia (CLL) abbvie.com ↗ |
| 2020-06-23 | AbbVie | IMBRUVICA® (ibrutinib) Seeks to Expand U.S. Label with Long-Term Data in Waldenström's Macroglobulinemia (WM) abbvie.com ↗ |
| 2020-04-21 | AbbVie | IMBRUVICA® (ibrutinib) Receives 11th FDA Approval abbvie.com ↗ |
| 2019-12-07 | AbbVie | More than Seven-Year Analysis of Early Treatment with IMBRUVICA® (ibrutinib) Monotherapy Showed Improved Progression-Free Survival in Patients with Mantle Cell Lymphoma (MCL) that Relapsed or Were Unresponsive to Prior Regimen abbvie.com ↗ |
| 2019-12-07 | AbbVie | IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Data Show High Rates of Disease Clearance in Previously Untreated Patients with Chronic Lymphocytic Leukemia (CLL) abbvie.com ↗ |
| 2019-12-07 | AbbVie | Extended Follow-up Phase 3 Data Underscore Sustained Efficacy and Safety of IMBRUVICA® (ibrutinib) in the Treatment of Chronic Lymphocytic Leukemia (CLL) abbvie.com ↗ |
| 2019-11-08 | AbbVie | 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 abbvie.com ↗ |
| 2019-01-28 | AbbVie | 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 abbvie.com ↗ |
| 2019-01-18 | AbbVie | AbbVie Provides Update on Phase 3 Study of Ibrutinib (IMBRUVICA®) in Metastatic Pancreatic Cancer abbvie.com ↗ |
| 2018-12-04 | AbbVie | 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 abbvie.com ↗ |
| 2018-12-03 | AbbVie | 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) abbvie.com ↗ |
| 2018-12-02 | AbbVie | 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.com ↗ |
| 2018-11-20 | AbbVie | AbbVie to Highlight Breadth of Innovative Science and Ongoing Commitment to Blood Cancer Patients with New Data From Studies of Ibrutinib and Venetoclax at 2018 American Society of Hematology Annual Meeting & Exposition abbvie.com ↗ |
| 2018-10-17 | AbbVie | 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.com ↗ |
| 2018-08-27 | AbbVie | 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.com ↗ |
| 2018-07-11 | AbbVie | AbbVie Provides Update on Phase 3 Study of Ibrutinib (IMBRUVICA®) in Blood Cancer Diffuse Large B-Cell Lymphoma (DLBCL) and Ongoing Ibrutinib Clinical Program abbvie.com ↗ |
| 2018-06-25 | AbbVie | 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 abbvie.com ↗ |
| 2018-06-03 | AbbVie | Phase 2 IMBRUVICA® (ibrutinib) Plus VENCLEXTA® (venetoclax) Early Data Show High Rates of Responses in Patients with Previously-Untreated Chronic Lymphocytic Leukemia (CLL) abbvie.com ↗ |
| 2018-06-01 | AbbVie | 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 abbvie.com ↗ |
| 2018-05-24 | AbbVie | IMBRUVICA® (ibrutinib) Plus GAZYVA® (obinutuzumab) Phase 3 iLLUMINATE Trial for First-Line Therapy of Chronic Lymphocytic Leukemia (CLL) Patients Met Primary Endpoint abbvie.com ↗ |
| 2017-12-11 | AbbVie | IMBRUVICA® (ibrutinib) Data Provide Insights Into Its Potential Treatment Benefits for Previously-Treated Chronic Graft-Versus-Host Disease -- A Serious, Possibly Life-Threatening Condition abbvie.com ↗ |
| 2017-12-09 | AbbVie | 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) abbvie.com ↗ |
| 2017-12-09 | AbbVie | IMBRUVICA® (ibrutinib) Patient-Reported Outcomes Data Detail Long-Term Improvement in Treatment Outcomes and Quality of Life Experience in Chronic Lymphocytic Leukemia (CLL) Patients abbvie.com ↗ |
| 2017-12-05 | AbbVie | IMBRUVICA® (ibrutinib) Plus Rituximab Phase 3 iNNOVATE Trial in Rare Waldenström's Macroglobulinemia Met Primary Endpoint abbvie.com ↗ |
| 2017-08-02 | AbbVie | 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 abbvie.com ↗ |
| 2017-06-05 | AbbVie | 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 abbvie.com ↗ |
| 2017-06-05 | AbbVie | Long-Term IMBRUVICA® (ibrutinib) 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 Disea abbvie.com ↗ |
| 2017-06-05 | AbbVie | Long-Term IMBRUVICA® (ibrutinib) 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 abbvie.com ↗ |
| 2017-05-30 | Novartis Pharmaceuticals | Novartis next generation CAR-T cell therapy CTL119 combined with ibrutinib shows high rate of responses in CLL patients novartis.com ↗ |
| 2017-05-14 | AbbVie | 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.com ↗ |
| 2017-04-04 | AbbVie | AbbVie Announces Ibrutinib (IMBRUVICA®) Supplemental New Drug Application for Previously Treated Chronic Graft-Versus-Host-Disease (cGVHD) Accepted for Review by U.S. FDA abbvie.com ↗ |
| 2017-01-19 | AbbVie | 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 abbvie.com ↗ |
| 2016-12-06 | AbbVie | 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 abbvie.com ↗ |
| 2016-12-05 | AbbVie | New Phase 2 Data Show Nearly Half of Patients with Relapsed/Refractory Marginal Zone Lymphoma (MZL) Respond to Treatment with Ibrutinib (IMBRUVICA®) abbvie.com ↗ |
| 2016-12-04 | AbbVie | Favorable Response Rates Suggest Promise of Ibrutinib (IMBRUVICA®) Combination Therapy in Two Common Types of Non-Hodgkin's Lymphoma abbvie.com ↗ |
| 2016-12-03 | AbbVie | 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.com ↗ |
| 2016-09-26 | AbbVie | AbbVie Announces Submission of a Supplemental New Drug Application for Ibrutinib (IMBRUVICA®) for Treatment of Marginal Zone Lymphoma abbvie.com ↗ |
| 2016-06-29 | AbbVie | 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.com ↗ |
| 2016-06-06 | AbbVie | 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 abbvie.com ↗ |
| 2016-05-31 | AbbVie | European Commission Approves IMBRUVICA® (ibrutinib) for First-Line Treatment of Patients with Chronic Lymphocytic Leukemia abbvie.com ↗ |
| 2016-05-09 | AbbVie | 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 abbvie.com ↗ |
| 2016-04-29 | AbbVie | European Medicines Agency Issues Positive Opinion for the Use of IMBRUVICA® (ibrutinib) as a First-Line Treatment for Chronic Lymphocytic Leukemia Patients abbvie.com ↗ |
| 2016-03-04 | AbbVie | IMBRUVICA® (ibrutinib) Approved by U.S. FDA for the First-line Treatment of Chronic Lymphocytic Leukemia abbvie.com ↗ |
| 2015-12-07 | AbbVie | IMBRUVICA® (Ibrutinib) Phase 3 RAY Data Show Significant Reductions in Disease Progression versus Temsirolimus in Relapsed/Refractory Mantle Cell Lymphoma Patients abbvie.com ↗ |
| 2015-12-07 | AbbVie | Combination Ibrutinib (IMBRUVICA®) Demonstrates a Strong Response Rate in Treatment-Naive Patients with Follicular Lymphoma abbvie.com ↗ |
| 2015-12-06 | AbbVie | Ibrutinib (IMBRUVICA®) Improves Survival in Treatment-Naive Chronic Lymphocytic Leukemia Patients in the Phase 3 RESONATE™-2 Trial abbvie.com ↗ |
| 2015-12-06 | AbbVie | Ibrutinib (IMBRUVICA®) Combination Data Show Promise in Patients with Relapsed/Refractory Multiple Myeloma abbvie.com ↗ |
| 2015-11-13 | AbbVie | AbbVie Submits IMBRUVICA® (ibrutinib) Phase III Combination Data to U.S. FDA abbvie.com ↗ |
| 2015-10-28 | AbbVie | IMBRUVICA® (ibrutinib) Awarded Prix Galien 2015 Best Pharmaceutical Agent abbvie.com ↗ |
| 2015-09-14 | AbbVie | AbbVie Announces Submission of a Supplemental New Drug Application for IMBRUVICA® (ibrutinib) for Treatment-Naive Chronic Lymphocytic Leukemia abbvie.com ↗ |
| 2015-07-10 | AbbVie | IMBRUVICA® (ibrutinib) Now Approved to Treat Waldenstrom's Macroglobulinemia in Europe abbvie.com ↗ |
| 2015-03-04 | AbbVie | AbbVie to Acquire Pharmacyclics, including its blockbuster product Imbruvica®, Creating an Industry Leading Hematological Oncology Franchise abbvie.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 357 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ibrutinib | “The purpose of the study is to investigate whether the combination of obinutuzumab and ibrutinib (administered up to 840 mg per day) might be useful for the treatment of CLL or...” NCT02611908 ↗335“Patients with newly diagnosed PCNSL were randomized to receive four 28-day cycles of ibrutinib or lenalidomide in combination with R-MPV (rituximab, methotrexate, procarbazine,...” PMID 39300447 ↗ Sep 2024 “Undetectable measurable residual disease (uMRD) is achievable in patients with chronic lymphocytic leukemia (CLL) with the BCL2-inhibitor venetoclax alone or combined with the...” PMID 35921541 ↗ Dec 2022 “Ibrutinib (IMBRUVICA®; PCI-32765; JNJ-54179060) is a first-in-class, potent, orally-administered covalently-binding small molecule inhibitor of Bruton's tyrosine kinase” NCT02747732 ↗ “Oral ibrutinib will be given between days 1 and 28 of each 28-day cycle and will be continued daily after completion of rituximab and lenalidomide.” NCT03703167 ↗ “Commercially available cBTKi (ibrutinib or acalabrutinib, or zanubrutinib) will be administered in accordance with its prescribing label.” NCT06524375 ↗ “Ibrutinib, a novel oral Bruton's tyrosine kinase inhibitor, has shown single-drug activity in relapsed or refractory B-cell malignancies.” PMID 25042202 ↗ Jul 2014 “Ibrutinib or lenalidomide may be used in patients who are no longer eligible for autologous HSCT after 2 cycles of immunochemotherapy” NCT03570892 ↗ “We evaluated ibrutinib (PCI-32765), a small-molecule irreversible inhibitor of BTK, in patients with B-cell malignancies.” PMID 23045577 ↗ Oct 2012 “Covalent BTK inhibitor (Ibrutinib 560 mg qd, Zanubrutinib 160 mg bid, or Orelabrutinib 150 mg qd) orally on Days 1-21.” NCT07350850 ↗ “Ibrutinib is the first-generation BTK inhibitror and Zanubrutinib is the second-generation BTK inhibitor.” NCT05020392 ↗ “Ibrutinib is a potent and selective inhibitor of Bruton Tyrosine Kinase (Btk).” NCT01500733 ↗ “Ibrutinib, a BTK inhibitor, was enrolled with a standard dose of 560mg qd.” NCT05744037 ↗ “a covalent BTK inhibitor (e.g., ibrutinib, acalabrutinib, zanubrutinib)” NCT06675123 ↗ “combined with ibrutinib 420 mg, orally, once daily, during 52 weeks” NCT02557516 ↗ “PCI-32765 (Ibrutinib) combined with rituximab” NCT01520519 ↗ “Cycle 2 to 6 (every 28 days) :Ibrutinib:” NCT02666898 ↗ “PCI-32765 (Ibrutinib)” NCT01779791 ↗ “PCI-32765 (ibrutinib)” NCT01969266 ↗ “• Ibrutinib” NCT06821542 ↗ “• Ibrutinib” NCT07124078 ↗ |
| Known as | CRA-032765 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1873475 ↗ |
| Known as | IBR | “Adding venetoclax (VEN) to ibrutinib (IBR) has shown synergy in preclinical MCL models.” PMID 34700344 ↗ Mar 2022 |
| Known as | Ibrutinib (IMBRUVICA) | “Ibrutinib (IMBRUVICA)” NCT02013128 ↗ |
| Known as | Imbruvica | “Ibrutinib (IMBRUVICA®; PCI-32765; JNJ-54179060) is a first-in-class, potent, orally-administered covalently-binding small molecule inhibitor of Bruton's tyrosine kinase” NCT02747732 ↗7“The purpose of this study is to test any good or bad effects of the study drug called of ibrutinib (also known as Imbruvica™).” NCT02315326 ↗ “Ibrutinib (also known by the brand name Imbruvica®) is a drug that reduces cancer cells' ability to multiply and survive.” PMID 36815271 ↗ Feb 2023 “Drug: ibrutinib ibrutinib 560mg administered orally once daily. Other Name: Imbruvica” NCT04994626 ↗ “Ibrutinib (Imbruvica®), Bortezomib (Velcade®)” NCT03129828 ↗ “Ibrutinib 140 MG Oral Capsule [Imbruvica]” NCT03280160 ↗ “Drug: Ibrutinib Oral Capsule [Imbruvica]” NCT03399513 ↗ |
| Known as | JNJ-54179060 | “Ibrutinib (PCI-32765; JNJ-54179060) is a first-in-class, potent, orally-administered covalently-binding small molecule inhibitor of Bruton's tyrosine kinase currently being...” NCT02689869 ↗2“Ibrutinib (IMBRUVICA®; PCI-32765; JNJ-54179060) is a first-in-class, potent, orally-administered covalently-binding small molecule inhibitor of Bruton's tyrosine kinase” NCT02747732 ↗ |
| Known as | PC-32765 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1873475 ↗ |
| Known as | PCI-32765 | “Ibrutinib (PCI-32765; JNJ-54179060) is a first-in-class, potent, orally-administered covalently-binding small molecule inhibitor of Bruton's tyrosine kinase currently being...” NCT02689869 ↗30“An Open-label, Single Arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 (Ibrutinib) in Patients With Relapsed or Refractory Chronic Lymphocytic...” NCT01744691 ↗ “A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Participants...” NCT01974440 ↗ “Ibrutinib (IMBRUVICA®; PCI-32765; JNJ-54179060) is a first-in-class, potent, orally-administered covalently-binding small molecule inhibitor of Bruton's tyrosine kinase” NCT02747732 ↗ “This is a Phase 1b, open-label, parallel-group, nonrandomized, multicenter study of PCI 32765 420 mg once daily oral (PO) administration” NCT01292135 ↗ “An Early Access Program (EAP) for Ibrutinib (PCI-32765) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)” NCT02437019 ↗ “A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia” NCT01578707 ↗ “An Open-Label Treatment Use Protocol for Ibrutinib (PCI-32765) in Subjects With Relapsed or Refractory Mantle Cell Lymphoma” NCT01833039 ↗ “We evaluated ibrutinib (PCI-32765), a small-molecule irreversible inhibitor of BTK, in patients with B-cell malignancies.” PMID 23045577 ↗ Oct 2012 “ibrutinib (PCI-32765), a first-in-class, oral covalent inhibitor of BTK designed for treatment of B-cell cancers” PMID 23782158 ↗ Jun 2013 “A Study of PCI-32765 (Ibrutinib) Versus Rituximab in Relapsed or Refractory Chronic Leukemia/Lymphoma” NCT01973387 ↗ “Ibrutinib (PCI-32765) 420 mg (3 x 140 mg capsules) will be administered orally once daily.” NCT02232386 ↗ “PCI-32765 (Ibrutinib)” NCT01855750 ↗ “PCI-32765 (Ibrutinib)” NCT01776840 ↗ |
| Known as | PCI-32765-00 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1873475 ↗ |
| Action | Inhibit | “inhibitor of BTK” PMID 23045577 ↗ Oct 2012 |
| Modality | Small molecule | “a small-molecule irreversible inhibitor of BTK” PMID 23045577 ↗ Oct 2012 |
| Route | Oral | “dose orally once per day” NCT00849654 ↗ |
| Target | BTK | “inhibitor of BTK” PMID 23045577 ↗ Oct 2012 |