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 · 32 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed B-cell chronic lymphocytic leukemia 6 milestones | |||||
| Filed | US (FDA) | IMBRUVICA | B-cell chronic lymphocytic leukemia | 2020-01-22 | “AbbVie announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for IMBRUVICA (ibrutinib)” abbvie.com ↗ “IMBRUVICA (ibrutinib) - Supplemental NDA Submitted to U.S. FDA” jnj.com ↗ |
| Filed | EU (EMA) | IMBRUVICA | B-cell chronic lymphocytic leukemia | 2020-01-20 | “submission of a Type II variation application to the European Medicines Agency (EMA) seeking to expand the label of IMBRUVICA® (ibrutinib)” jnj.com ↗ “IMBRUVICA (ibrutinib) - Supplemental NDA Submitted to U.S. FDA and Type II Variation Submitted to EMA” jnj.com ↗ |
| Filed | US (FDA) | IMBRUVICA | B-cell chronic lymphocytic leukemia | 2019-11-08 | “today announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for IMBRUVICA ® (ibrutinib)” abbvie.com ↗ |
| Filed | EU (EMA) | IMBRUVICA | B-cell chronic lymphocytic leukemia | 2015-10-30 | “Janssen Submits Application to the EMA to Expand Use of IMBRUVICA® (ibrutinib) in Previously Untreated Chronic Lymphocytic Leukaemia Patients” jnj.com ↗ |
| Filed | US (FDA) | IMBRUVICA | B-cell chronic lymphocytic leukemia | 2015-09-14 | “In the U.S., a supplemental new drug application was submitted to the FDA for IMBRUVICA (ibrutinib) for use in treatment-naïve patients with chronic lymphocytic leukemia.” jnj.com ↗ “IMBRUVICA (ibrutinib) Supplemental New Drug Application for Treatment-naïve Chronic Lymphocytic Leukemia Submitted to the U.S.” jnj.com ↗ |
| Filed | US (FDA) | IMBRUVICA | B-cell chronic lymphocytic leukemia | 2014-04-08 | “today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICATM™ (ibrutinib) to the U.S. Food and Drug Administration (FDA)” jnj.com ↗ |
| Filed chronic graft versus host disease 1 milestone | |||||
| Filed | US (FDA) | IMBRUVICA | chronic graft versus host disease | 2017-04-04 | “Application was submitted to the U.S. Food and Drug Administration for IMBRUVICA (ibrutinib) for the treatment of chronic Graft-Versus-Host Disease” jnj.com ↗ “accepted for review by the U.S. Food and Drug Administration (FDA) for ibrutinib (IMBRUVICA®) in chronic graft-versus-host-disease (cGVHD)” abbvie.com ↗ “accepted for review a supplemental New Drug Application for IMBRUVICA in chronic graft-versus-host-disease (cGVHD)” abbvie.com ↗ |
| Filed chronic lymphocytic leukemia/small lymphocytic lymphoma 1 milestone | |||||
| Filed | US (FDA) | IMBRUVICA | chronic lymphocytic leukemia/small lymphocytic lymphoma | 2015-11-13 | “a supplemental New Drug Application (sNDA) for IMBRUVICA (ibrutinib) has been submitted to the U.S. Food and Drug Administration (FDA)” jnj.com ↗ “AbbVie submitted a supplemental New Drug Application (sNDA) for ibrutinib (IMBRUVICA®) to the U.S. Food and Drug Administration (FDA)” abbvie.com ↗ |
| Filed mantle cell lymphoma 2 milestones | |||||
| Filed | EU (EMA) | IMBRUVICA | mantle cell lymphoma | 2024-12-18 | “Johnson & Johnson submits application to the European Medicines Agency seeking approval of a new indication for IMBRUVICA®” jnj.com ↗ “The submission seeks approval for an indication extension of IMBRUVICA®(ibrutinib)” jnj.com ↗ |
| Filed | EU (EMA) | IMBRUVICA | mantle cell lymphoma | 2022-03-08 | “today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new indication for IMBRUVICA®(ibrutinib)” jnj.com ↗ |
| Filed marginal zone lymphoma 1 milestone | |||||
| Filed | US (FDA) | IMBRUVICA | marginal zone lymphoma | 2016-09-26 | “submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for ibrutinib (IMBRUVICA ® ) to treat patients with marginal zone lymphoma (MZL).” abbvie.com ↗ “AbbVie announced the submission of a supplemental New Drug Application (sNDA) to the U.S. FDA for IMBRUVICA to treat patients with marginal zone lymphoma (MZL).” abbvie.com ↗ |
| Filed Waldenstrom macroglobulinemia 4 milestones | |||||
| Filed | US (FDA) | IMBRUVICA | Waldenstrom macroglobulinemia | 2020-06-23 | “FDA will review a supplemental New Drug Application (sNDA) for IMBRUVICA ® (ibrutinib) in combination with rituximab for the treatment of Waldenström's macroglobulinemia (WM)” abbvie.com ↗ |
| Filed | US (FDA) | IMBRUVICA | Waldenstrom macroglobulinemia | 2018-06-01 | “IMBRUVICA as a combination therapy in WM was submitted to the U.S. Food and Drug Administration” abbvie.com ↗ |
| Filed | EU (EMA) | IMBRUVICA | Waldenstrom macroglobulinemia | 2014-12-01 | “Application Submitted To The EMA To Expand The Therapeutic Indication For IMBRUVICA® (ibrutinib) To Include Treatment Of Waldenström's Macroglobulinemia” jnj.com ↗ |
| Filed | US (FDA) | IMBRUVICA | Waldenstrom macroglobulinemia | 2014-10-20 | “IMBRUVICA® (ibrutinib) Supplemental New Drug Application Submitted to the U.S. FDA for Waldenström's macroglobulinemia” jnj.com ↗ |
| Approved Indication not stated 5 milestones | |||||
| 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 ↗ |
| Filed | EU (EMA) | — | chronic lymphocytic leukemia, mantle cell lymphoma | 2013-10-30 | “submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ibrutinib” jnj.com ↗ |
| Filed | US (FDA) | — | chronic lymphocytic leukemia, mantle cell lymphoma | 2013-07-10 | “Janssen Research & Development, LLC announced the submission of a New Drug Application for ibrutinib to the U.S. Food and Drug Administration (FDA)” jnj.com ↗ |
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EU approved 2014
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News releases announcing trial results or a regulatory action · 190
| Date | Issuer | Release |
|---|---|---|
| 2026-09-28 | Innovent Biologics (Suzhou) Co. Ltd. | Results Jaypirca® (pirtobrutinib) Approved in China for a New Indication in Chronic Lymphocytic Leukemia (CLL) /Small Lymphocytic Lymphoma (SLL) Across All Lines of Therapy innoventbio.com ↗
Pirtobrutinib achieved a numerically higher ORR compared to ibrutinib. |
| 2025-12-07 | Eli Lilly and Company | Results Lilly's Jaypirca (pirtobrutinib) met its primary endpoint in first-of-its-kind, head-to-head Phase 3 study versus Imbruvica (ibrutinib) lilly.com ↗
Pirtobrutinib met its primary endpoint of non-inferiority on overall response rate (ORR) compared to ibrutinib (87.0% [95% CI, 82.90-90.44] versus 78.5% [95% CI, 73.73-82.85]; p<0.0001) in the intent-to-treat (ITT) population. |
| 2025-12-02 | AbbVie | Results AbbVie to Feature New Data at ASH 2025 Showcasing Continued Advances Across Novel Treatment Modalities in Multiple Blood Cancers abbvie.com ↗ |
| 2025-07-29 | Eli Lilly and Company | Results Lilly's Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible) BTK inhibitor, met its primary endpoint in a head-to-head Phase 3 trial versus Imbruvica (ibrutinib) in CLL/SLL lilly.com ↗
ORR favored pirtobrutinib with a nominal P-value for superiority1 (p <0.05). |
| 2025-07-24 | Zydus Lifesciences Limited | Regulatory Zydus receives tentative approval from USFDA for Ibrutinib tablets 140 mg, 280 mg, and 420 mg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received tentative approval from the United States Food and Drug Administration (USFDA) for Ibrutinib tablets 140 mg, 280 mg, and 420 mg (USRLD: Imbruvica® tablets, 140 mg, 280 mg and 420 mg). |
| 2025-07-23 | Janssen Research & Development, LLC | Regulatory European Commission approves IMBRUVICA® (ibrutinib) as the first targeted therapy for patients with previously untreated mantle cell lymphoma who would be eligible for autologous stem cell transplant jnj.com ↗
Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the European Commission (EC) has approved an indication extension of IMBRUVICA®(ibrutinib) in frontline mantle cell lymphoma (MCL). |
| 2025-07-23 | Janssen Research & Development, LLC | Regulatory European Commission approves IMBRUVICA® (ibrutinib) as the first targeted therapy for patients with previously untreated mantle cell lymphoma who would be eligible for autologous stem cell transplant jnj.com ↗ |
| 2025-06-20 | Janssen Research & Development, LLC | Regulatory IMBRUVICA® (ibrutinib) receives positive CHMP opinion for the treatment of patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplant jnj.com ↗ |
| 2025-06-20 | Janssen Research & Development, LLC | Regulatory IMBRUVICA® (ibrutinib) receives positive CHMP opinion for the treatment of patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplant jnj.com ↗
IMBRUVICA® (ibrutinib) receives positive CHMP opinion for the treatment of patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplant |
| 2025-06-12 | Janssen Research & Development, LLC | Results Significant efficacy benefit of IMBRUVICA® (ibrutinib) plus venetoclax versus acalabrutinib plus venetoclax in frontline treatment of patients with chronic lymphocytic leukaemia suggested by indirect treatment comparison jnj.com ↗
The data were featured in a poster presentation at the 30thEuropean Hematology Association (EHA) Congress (Poster presentation #PF587) and reported that the I+V regimen yielded significantly better efficacy when compared to the A+V regimen. |
| 2025-06-12 | Janssen Research & Development, LLC | Results Significant efficacy benefit of IMBRUVICA® (ibrutinib) plus venetoclax versus acalabrutinib plus venetoclax in frontline treatment of patients with chronic lymphocytic leukaemia suggested by indirect treatment comparison jnj.com ↗
The data were featured in a poster presentation at the 30th European Hematology Association (EHA) Congress (Poster presentation #PF587) and reported that the I+V regimen yielded significantly better efficacy when compared to the A+V regimen. |
| 2024-12-18 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits application to the European Medicines Agency seeking approval of a new indication for IMBRUVICA® (ibrutinib) in adult patients with previously untreated mantle cell lymphoma (MCL) who are eligible for autologous stem cell transplant jnj.com ↗
Janssen-Cilag International NV, a Johnson & Johnson company, today announced the submission of a Type II variation application to the European Medicines Agency (EMA). |
| 2024-12-18 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits application to the European Medicines Agency seeking approval of a new indication for IMBRUVICA® (ibrutinib) in adult patients with previously untreated mantle cell lymphoma (MCL) who are eligible for autologous stem cell transplant jnj.com ↗
The submission seeks approval for an indication extension of IMBRUVICA ® (ibrutinib) in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL), who are eligible for autologous stem cell transplant (transplant). |
| 2024-12-09 | Bristol-Myers Squibb | Results Bristol Myers Squibb Highlights Progress of Cell Therapy Portfolio at ASH 2024 with Long-Term Survival Data and Results from Expanding Pipeline bms.com ↗
Grade ≥ 3 treatment emergent adverse events (TEAEs) occurred in 48 (86%) of patients, most commonly neutropenia (52%) and anemia (41%), with no Grade 5 TEAEs. |
| 2024-06-14 | Janssen Research & Development, LLC | Results Updated Phase 2 CAPTIVATE study results demonstrate sustained clinical benefit of fixed-duration IMBRUVICA® (ibrutinib) plus venetoclax as first-line treatment for patients with chronic lymphocytic leukaemia, including those with high-risk disease jnj.com ↗
At 5.5-years of follow-up, the FD regimen continues to demonstrate a clinically meaningful progression-free survival (PFS), both in the overall population and in those with high-risk genomic features. |
| 2024-06-14 | Janssen Research & Development, LLC | Results Findings from landmark RESONATE-2 study confirm sustained survival benefit of IMBRUVICA® (ibrutinib) for first-line chronic lymphocytic leukaemia treatment with up to 10 years follow-up jnj.com ↗
With up to ten years of follow-up, patients treated with ibrutinib demonstrated a significant and sustained progression-free survival (PFS) benefit versus patients treated with chlorambucil. |
| 2024-06-14 | Janssen Research & Development, LLC | Results Updated Phase 2 CAPTIVATE study results demonstrate sustained clinical benefit of fixed-duration IMBRUVICA® (ibrutinib) plus venetoclax as first-line treatment for patients with chronic lymphocytic leukaemia, including those with high-risk disease jnj.com ↗
At 5.5-years of follow-up, the FD regimen continues to demonstrate a clinically meaningful progression-free survival (PFS), both in the overall population and in those with high-risk genomic features. |
| 2024-06-14 | Janssen Research & Development, LLC | Results Findings from landmark RESONATE-2 study confirm sustained survival benefit of IMBRUVICA® (ibrutinib) for first-line chronic lymphocytic leukaemia treatment with up to 10 years follow-up jnj.com ↗
No patients discontinued ibrutinib due to progressive disease in years 9–10. |
| 2024-06-04 | Ascentage Pharma Group Inc. | Results Live from ASCO 2024 | Ascentage Pharma Releases Updated Data Showing Promising Efficacy and Safety of Lisaftoclax in Patients with WM ascentage.com ↗
In addition, no potential drug-drug interactions (DDIs) with ibrutinib were observed in the study. |
| 2024-05-24 | BeOne Medicines | Results BRUKINSA® Data at ASCO Underscore Differentiated Clinical Profile for Treatment of CLL and SLL beonemedicines.com ↗
BRUKINSA led to statistically significant improvements in PFS, as well as a trend toward improvement in OS, vs. ibrutinib and bendamustine + rituximab/idelalisib + rituximab (BR/IR). |
| 2024-05-14 | BeOne Medicines | Results BeiGene Highlights New Hematology Portfolio and Pipeline Data at EHA2024 beonemedicines.com ↗
patients in the ibrutinib arm initiated new and/or a new class of anti-hypertensive medications more frequently than patients in the BRUKINSA arm |
| 2024-02-26 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson Announces Expansion of IMBRUVICA® (ibrutinib) Label in the U.S. to Include Oral Suspension Formulation for Adult Patients in its Approved Indications jnj.com ↗
Johnson & Johnson, in collaboration with its alliance partner, Pharmacyclics LLC, an AbbVie Company, announced today that the U.S. Food and Drug Administration (FDA) has approved a label expansion for IMBRUVICA® (ibrutinib) with an oral suspension formulation for adult patients in the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); Waldenström’s macroglobulinemia (WM); and chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. |
| 2023-12-12 | Curis, Inc. | Results Curis Announces Initial Combination Study Data from its TakeAim Lymphoma Study curis.com ↗
Patients with PCNSL who had a history of failed BTKi therapy showed a particularly noteworthy response: 3 out of 5 evaluable PCNSL patients achieved a Complete Response (CR), with durability ranging from 0.3 – 8.9 months. |
| 2023-11-28 | BeOne Medicines | Results BeiGene to Present New Data Highlighting Hematology Portfolio and Pipeline Strengths at ASH 2023 beonemedicines.com ↗
BRUKINSA® (zanubrutinib) continues to show progression free survival (PFS) benefit compared with ibrutinib in extended follow-up of patients with relapsed/refractory (R/R) chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL) in the ALPINE trial |
| 2023-06-15 | BeOne Medicines | Results BeiGene Highlights Significant BRUKINSA® (zanubrutinib) Data at the 17th International Conference on Malignant Lymphoma beonemedicines.com ↗
In a subgroup analysis of the Phase 3 ALPINE trial (NCT03734016), BRUKINSA showed improved PFS over ibrutinib in patients in China with R/R chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), consistent with the global study population. |
| 2023-06-06 | Ascentage Pharma Group Inc. | Results Live from ASCO 2023 | Ascentage Pharma Releases the First Dataset of Lisaftoclax in WM, Revealing Encouraging Therapeutic Potential ascentage.com ↗
Lisaftoclax alone or combined with ibrutinib/rituximab demonstrated favorable safety and promising activity in patients with treatment-naïve or BTKi-refractory WM, with negligible risk of DDI between lisaftoclax and ibrutinib. |
| 2023-04-06 | Janssen Research & Development, LLC | Regulatory Update on IMBRUVICA® (ibrutinib) U.S. Accelerated Approvals for Mantle Cell Lymphoma and Marginal Zone Lymphoma Indications jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson, in collaboration with its alliance partner, Pharmacyclics, an AbbVie Company, announced today the intent to voluntarily withdraw the U.S. indications for IMBRUVICA®(ibrutinib) for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, and for the treatment of patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. |
| 2023-04-06 | Janssen Research & Development, LLC | Regulatory Update on IMBRUVICA® (ibrutinib) U.S. Accelerated Approvals for Mantle Cell Lymphoma and Marginal Zone Lymphoma Indications jnj.com ↗
This decision was made in consultation with the U.S. Food and Drug Administration (FDA), consistent with FDA procedural guidance on accelerated approvals. |
| 2023-04-06 | AbbVie | Regulatory Update on IMBRUVICA® (ibrutinib) U.S. Accelerated Approvals for Mantle Cell Lymphoma and Marginal Zone Lymphoma Indications abbvie.com ↗
This voluntary action is due to requirements related to the accelerated approval status granted by the U.S. FDA for MCL and MZL. |
| 2022-12-16 | Janssen Research & Development, LLC | Regulatory Janssen Withdraws Application in European Union Seeking Approval of IMBRUVICA® (ibrutinib) for the Treatment of Patients with Untreated Mantle Cell Lymphoma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the company has withdrawn its application seeking a change to the marketing authorisation for IMBRUVICA® (ibrutinib). |
| 2022-12-13 | BeOne Medicines | Results BeiGene’s BRUKINSA® (zanubrutinib) Demonstrated Superior Progression-Free Survival Over IMBRUVICA® (ibrutinib) in Chronic Lymphocytic Leukemia in Late-Breaker at ASH beonemedicines.com ↗
In this final analysis, BRUKINSA achieved superior PFS over ibrutinib (HR: 0.65 [95% CI, 0.49-0.86] p=0.0024, for both Independent Review Committee [IRC] and investigator). |
| 2022-12-12 | Janssen Research & Development, LLC | Results Real-World Study Shows Patients Treated with IMBRUVICA® (ibrutinib) Were Less Likely to Initiate a Next-Line Treatment than Patients on Acalabrutinib in First-line Chronic Lymphocytic Leukemia jnj.com ↗
These results demonstrate the possible impact of using ibrutinib versus acalabrutinib in the front-line setting and provide healthcare professionals with additional data showing differences in time to next treatment. |
| 2022-12-10 | Janssen Research & Development, LLC | Results New Results from the Phase 3 GLOW Study of Fixed-Duration Treatment with IMBRUVICA® (ibrutinib) Plus Venetoclax Demonstrate Robust Efficacy and Sustained Response in Older, Unfit Patients with Previously Untreated Chronic Lymphocytic Leukemia jnj.com ↗
With a median 46 months of follow-up, I+V reduced the risk of disease progression or death by 79 percent versus Clb+O (Hazard Ratio (HR) 0.214; [95 percent Confidence Interval (CI), 0.138-0.334];p<0.0001). |
| 2022-12-10 | Janssen Research & Development, LLC | Results New Results from the Phase 3 GLOW Study of Fixed-Duration Treatment with IMBRUVICA® (ibrutinib) Plus Venetoclax Demonstrate Robust Efficacy and Sustained Response in Older, Unfit Patients with Previously Untreated Chronic Lymphocytic Leukemia jnj.com ↗
With a median 46 months of follow-up, I+V reduced the risk of disease progression or death by 79 percent versus Clb+O (Hazard Ratio (HR) 0.214; [95 percent Confidence Interval (CI), 0.138-0.334]; p<0.0001). |
| 2022-12-10 | AbbVie | Results AbbVie Presents Data at the 64th American Society of Hematology (ASH) Annual Meeting Adds to Robust IMBRUVICA® (ibrutinib) Science abbvie.com ↗
During the three-year post-randomization period, adverse events (AEs) of any grade for patients treated with IMBRUVICA ® were arthralgia (4/41), hypertension (2/41), neutropenia (1/41) and diarrhea (1/41). |
| 2022-11-30 | AstraZeneca | Results AstraZeneca showcases strength of haematology portfolio and pipeline across multiple hard-to-treat conditions at ASH 2022 astrazeneca.com ↗
A post-hoc safety analysis from the head-to-head ELEVATE-RR Phase III trial of Calquence versus ibrutinib will further support tolerability differences of Calquence in relapsed or refractory CLL. |
| 2022-11-22 | BeOne Medicines | Results BeiGene to Present Final PFS Results from ALPINE Trial Demonstrating Superior PFS for BRUKINSA® Versus IMBRUVICA® in Late-Breaking Oral Session at ASH 2022 beonemedicines.com ↗
In this final PFS analysis, BRUKINSA achieved superior PFS compared with ibrutinib, as assessed by both Independent Review Committee (IRC) and investigator (HR: 0.65 [95% CI, 0.49-0.86] p =.0024, for both investigator and IRC). |
| 2022-10-12 | BeOne Medicines | Results BeiGene Announces Positive Topline Results from Final Progression-Free Survival Analysis of BRUKINSA® (zanubrutinib) Compared to IMBRUVICA® (ibrutinib) in Phase 3 Chronic Lymphocytic Leukemia (CLL) Trial beonemedicines.com ↗
today announced that BRUKINSA® (zanubrutinib) achieved superior Progression-Free Survival (PFS) versus IMBRUVICA® (ibrutinib) in a final analysis of the Phase 3 ALPINE trial, as assessed by an independent review committee (IRC) and investigator. |
| 2022-08-24 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves IMBRUVICA® (ibrutinib) as First and Only BTKi Treatment for Pediatric Patients with Chronic Graft-Versus-Host Disease jnj.com ↗
IMBRUVICA®is now the first FDA-approved therapy for these younger patients who previously had no approved treatment options for this life-threatening disease. |
| 2022-08-24 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves IMBRUVICA® (ibrutinib) as First and Only BTKi Treatment for Pediatric Patients with Chronic Graft-Versus-Host Disease jnj.com ↗ |
| 2022-08-24 | AbbVie | Regulatory Children with Chronic Graft Versus Host Disease (cGVHD) May Now Be Prescribed IMBRUVICA® (ibrutinib) abbvie.com ↗
The U.S. Food and Drug Administration approved the use of IMBRUVICA for the treatment of pediatric patients one year and older with cGVHD after failure of one or more lines of systemic therapy |
| 2022-08-04 | Janssen Research & Development, LLC | Regulatory European Commission Approves IMBRUVICA® (ibrutinib) in a Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL) jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission granted marketing authorisation for the expanded use of IMBRUVICA®(ibrutinib) in an all-oral, fixed-duration (FD) treatment combination with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukaemia (CLL). |
| 2022-08-04 | Janssen Research & Development, LLC | Regulatory European Commission Approves IMBRUVICA® (ibrutinib) in a Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL) jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission granted marketing authorisation for the expanded use of IMBRUVICA® (ibrutinib) in an all-oral, fixed-duration (FD) treatment combination with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukaemia (CLL). |
| 2022-06-24 | Janssen Research & Development, LLC | Regulatory Janssen Receives Positive CHMP Opinion for IMBRUVICA® (ibrutinib) in a Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL) jnj.com ↗
This recommendation brings us one step closer to European Commission (EC) approval and to providing patients with an all-oral, once daily, fixed-duration regimen, which until this point has not been available with the BTK inhibitor class of treatments. |
| 2022-06-24 | Janssen Research & Development, LLC | Regulatory Janssen Receives Positive CHMP Opinion for IMBRUVICA® (ibrutinib) in a FixedDuration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL) jnj.com ↗ |
| 2022-06-10 | Janssen Research & Development, LLC | Results New IMBRUVICA® (ibrutinib) Data in Fixed-Duration Combination Regimen Presented at EHA 2022 Shows Deep, Durable Response at Three Years in Untreated Chronic Lymphocytic Leukemia jnj.com ↗
Updated data from the FD cohort with three years of follow-up shows that I+V continues to demonstrate deep and durable responses and clinically meaningful progression-free survival (PFS) and overall survival (OS) in the first-line treatment setting. |
| 2022-06-10 | BeOne Medicines | Results BeiGene Highlights Growing Portfolio and Pipeline Targeting Hematologic Malignancies at European Hematology Association 2022 Congress beonemedicines.com ↗
Long-term safety and efficacy results from the Phase 3 ASPEN trial of zanubrutinib versus ibrutinib in patients with Waldenström macroglobulinemia |
| 2022-06-04 | Curis, Inc. | Results Curis Announces Encouraging Emavusertib Data at the 2022 American Society of Clinical Oncology Annual Meeting (ASCO) curis.com ↗
TakeAim Lymphoma data for the combination of emavusertib plus ibrutinib show tumor reduction in 8 of 9 evaluable patients, including 2 complete responses and 2 partial responses |
| 2022-06-03 | Janssen Research & Development, LLC | Results Phase 3 SHINE Results Show IMBRUVICA® (ibrutinib)-Based Combination Regimen Significantly Reduced the Risk of Disease Progression or Death in Older Patients with Newly Diagnosed Mantle Cell Lymphoma jnj.com ↗ |
| 2022-06-03 | Janssen Research & Development, LLC | Results Phase 3 SHINE Results Show IMBRUVICA® (ibrutinib)-Based Combination Regimen Significantly Reduced the Risk of Disease Progression or Death in Older Patients with Newly Diagnosed Mantle Cell Lymphoma jnj.com ↗
Phase 3 SHINE Results Show IMBRUVICA® (ibrutinib)-Based Combination Regimen Significantly Reduced the Risk of Disease Progression or Death in Older Patients with Newly Diagnosed Mantle Cell Lymphoma |
| 2022-05-26 | BeOne Medicines | Results BeiGene Clinical Data Presentations at 2022 ASCO Annual Meeting Demonstrate Mature and Growing Oncology Portfolio beonemedicines.com ↗ |
| 2022-05-12 | Curis, Inc. | Results Curis Announces Abstracts Accepted for Presentation at the European Hematology Association 2022 Congress (EHA) curis.com ↗
Data in the abstract indicates that the combination has shown signs of early anti-cancer activity, including in patients with prior BTK inhibitor use, and the regimen appears to be well tolerated. |
| 2022-04-11 | BeOne Medicines | Results IRC Determines BRUKINSA® (Zanubrutinib) Demonstrates Superior Overall Response Rate Versus Ibrutinib in Final Response Analysis of ALPINE Trial in Chronic Lymphocytic Leukemia beonemedicines.com ↗ |
| 2022-03-08 | Janssen Research & Development, LLC | Regulatory Janssen Seeks Approval of a New Indication for IMBRUVICA® (ibrutinib) for Use in Patients with Untreated Mantle Cell Lymphoma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new indication for IMBRUVICA®(ibrutinib) in combination with bendamustine and rituximab (BR) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are unsuitable for autologous stem cell transplantation (ASCT). |
| 2022-03-08 | Janssen Research & Development, LLC | Regulatory Janssen Seeks Approval of a New Indication for IMBRUVICA® (ibrutinib) for Use in Patients with Untreated Mantle Cell Lymphoma jnj.com ↗ |
| 2022-02-28 | AbbVie | Regulatory AbbVie Seeks New Indication for IMBRUVICA® (ibrutinib) in Pediatric Patients with Chronic Graft Versus Host Disease (cGVHD) abbvie.com ↗
today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for IMBRUVICA ® (ibrutinib) |
| 2021-12-12 | AstraZeneca | Results Calquence reduced the risk of disease progression or death by 71% vs. standard of care combinations at three years in the ASCEND Phase III trial astrazeneca.com ↗ |
| 2021-12-11 | Janssen Research & Development, LLC | Results New Data from Phase 3 GLOW Study Show Fixed-Duration Treatment with IMBRUVICA® (ibrutinib) Plus Venetoclax Demonstrated Deeper and Sustained Undetectable Minimal Residual Disease Outcomes in First-Line Chronic Lymphocytic Leukemia jnj.com ↗
New secondary endpoint data from the Phase 3 GLOW study (NCT03462719) showed that fixed-duration treatment with I+V resulted in undetectable minimal residual disease (uMRD) responses that were deeper compared to patients treated with chlorambucil plus obinutuzumab |
| 2021-11-30 | Janssen Research & Development, LLC | Regulatory Janssen Seeks Approval of IMBRUVICA®(ibrutinib) in a Fixed-Duration Regimen for Patients with Untreated Chronic Lymphocytic Leukaemia (CLL) jnj.com ↗ |
| 2021-11-04 | ADC Therapeutics S.A. | Results ADC Therapeutics Announces Abstracts to be Presented at the 63rd ASH Annual Meeting adctherapeutics.com ↗
We are also encouraged by the anti-tumor activity and manageable safety profile of ZYNLONTA in combination with ibrutinib. |
| 2021-07-21 | Zydus Lifesciences Limited | Regulatory Zydus Cadila receives tentative approval from the USFDA for Ibrutinib Tablets zyduslife.com ↗
Zydus Cadila has received tentative approval from the USFDA to market Ibrutinib Tablets, in the strengths of 140 mg, 280 mg, 420 mg and 560 mg (US RLD: Imbruvica Tablets). |
| 2021-06-18 | ADC Therapeutics S.A. | Results ADC Therapeutics Presents Updated ZYNLONTA™ (loncastuximab tesirine-lpyl) Clinical Data at 16th Annual International Conference on Malignant Lymphoma adctherapeutics.com ↗
We’re also pleased that the updated data from the LOTIS-3 clinical trial demonstrate the encouraging antitumor activity and manageable toxicity profile of ZYNLONTA in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma. |
| 2021-06-12 | Janssen Research & Development, LLC | Results New Phase 3 Study Results Show IMBRUVICA® (ibrutinib)-Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukemia jnj.com ↗
The study demonstrated superior progression-free survival (PFS) of a once-daily, all-oral, fixed-duration regimen of I+V versus Clb+O as first-line treatment of CLL; the study also showed improved duration of remission and significantly improved depth of remission. |
| 2021-06-12 | Janssen Research & Development, LLC | Results New Phase 3 Study Results Show IMBRUVICA® (ibrutinib)-Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukemia jnj.com ↗ |
| 2021-06-12 | AbbVie | Results 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 ↗
The PFS benefit with I+V was consistent across pre-specified subgroups, including patients 65 years and older and those with comorbidities (CIRS >6). |
| 2021-06-11 | BeOne Medicines | Results BeiGene Presents ALPINE Results at EHA2021 Demonstrating Both Efficacy and Safety Advantages of BRUKINSA® (Zanubrutinib) in Head-to-Head Comparison to Ibrutinib in Chronic Lymphocytic Leukemia beonemedicines.com ↗
The Phase 3 ALPINE trial met the primary endpoint at interim analysis, with BRUKINSA showing superiority in investigator-assessed overall response rate versus ibrutinib |
| 2021-06-07 | AstraZeneca | Results Calquence demonstrated fewer incidences of atrial fibrillation versus ibrutinib in previously treated patients with chronic lymphocytic leukaemia and sustained patient benefit at four years in the front-line setting astrazeneca.com ↗
Patients treated with Calquence had a statistically significantly lower incidence of all-grade atrial fibrillation compared with patients treated with ibrutinib (9.4% versus 16.0%), a key secondary endpoint. |
| 2021-06-07 | AbbVie | Results 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 ↗
The ibrutinib and venetoclax cohort met its primary endpoint of complete response (CR) rate of 56% (95% CI 48-64) among patients without del(17p), 70 years old or younger and with 27.9 months of follow up. |
| 2021-06-04 | AbbVie | Results 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 ↗
AbbVie (NYSE: ABBV), today announced extended long-term data from the Phase 3 RESONATE-2 study ( PCYC-1115/1116 ) evaluating single-agent IMBRUVICA (ibrutinib) versus chlorambucil with up to seven years of follow-up in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). |
| 2021-06-01 | BeOne Medicines | Results BeiGene Announces First Presentation of the Phase 3 ALPINE Trial Comparing BRUKINSA® (Zanubrutinib) to Ibrutinib in Chronic Lymphocytic Leukemia to Be Featured in Presidential Symposium at EHA2021 beonemedicines.com ↗
BRUKINSA demonstrated superior objective response rate by investigator assessment in the planned interim analysis |
| 2021-05-19 | Janssen Research & Development, LLC | Results IMBRUVICA® (ibrutinib)-Based Combination Regimen as a Fixed-Duration, First-Line Treatment for Chronic Lymphocytic Leukemia Demonstrates High Rates of Disease Control jnj.com ↗
At a median follow-up of 27.9 months, the complete response (CR) rate in the overall population was 56 percent (n=88; 95 percent Confidence Interval [CI], 48–64) and was consistent across high-risk subgroups. |
| 2021-05-19 | Janssen Research & Development, LLC | Results IMBRUVICA® (ibrutinib)-Based Combination Regimen as a Fixed-Duration, FirstLine Treatment for Chronic Lymphocytic Leukemia Demonstrates High Rates of Disease Control jnj.com ↗ |
| 2021-04-28 | BeOne Medicines | Results BRUKINSA® (Zanubrutinib) Demonstrates Superior Objective Response Rate by Investigator Assessment and Reduced Rates of Atrial Fibrillation or Flutter at Interim Analysis in Head-to-Head Trial Against Ibrutinib in Chronic Lymphocytic Leukemia beonemedicines.com ↗
Compared to ibrutinib, BRUKINSA demonstrated a statistically significant lower risk of atrial fibrillation or flutter, which is characterized by an irregular heartbeat that can lead to blood clots, stroke, heart failure and other heart-related complications. |
| 2021-04-12 | NATCO Pharma Ltd. | Regulatory NATCO receives tentative approval for Ibrutinib tablets (generic for IMBRUVICA ®) ANDA in the US market natcopharma.co.in ↗
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that its marketing and distribution partner Alvogen Pine Brook LLC, has received tentative approval for our Abbreviated New Drug Application (ANDA) for Ibrutinib Tablets 560mg, 420mg, 280mg and 140mg strengths (generic for IMBRUVICA®), from the U.S. Food and Drug Administration (USFDA). |
| 2021-04-08 | Zydus Lifesciences Limited | Regulatory Zydus Cadila receives final approval from the USFDA for Ibrutinib Capsules zyduslife.com ↗
Zydus Cadila has received final approval from the USFDA to market Ibrutinib Capsules, 70 mg and 140 mg (US RLD: Imbruvica Capsules). |
| 2021-01-25 | AstraZeneca | Results Calquence met primary efficacy endpoint in head-to-head trial against ibrutinib in chronic lymphocytic leukaemia astrazeneca.com ↗
Positive high-level results from the ELEVATE-RR Phase III trial showed AstraZeneca’s Calquence (acalabrutinib) met the primary endpoint demonstrating non-inferior progression-free survival (PFS) for adults with previously treated, high-risk chronic lymphocytic leukaemia (CLL) compared to ibrutinib. |
| 2020-12-23 | AbbVie | Regulatory IMBRUVICA® (ibrutinib) U.S. Prescribing Information Updated to Include Long-Term Data for Waldenström's Macroglobulinemia (WM) abbvie.com ↗ |
| 2020-12-07 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents Data Evaluating Potential of Liso-cel Across Leukemia and Lymphomas at ASH 2020 bms.com ↗
Liso-cel elicited high overall response rates in relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma both as monotherapy and in combination with ibrutinib |
| 2020-12-07 | ADC Therapeutics S.A. | Results ADC Therapeutics Announces Updated Clinical Data on Lead Antibody Drug Conjugate Programs Loncastuximab Tesirine (Lonca) and Camidanlumab Tesirine (Cami) Presented at 62nd American Society of Hematology Annual Meeting adctherapeutics.com ↗
LOTIS 3 interim results highlight potential of Lonca in combination with ibrutinib in relapsed or refractory diffuse large B-cell lymphoma and mantle cell lymphoma patients |
| 2020-12-06 | Janssen Research & Development, LLC | Results New Data Demonstrate Long-Term Benefit of IMBRUVICA® (ibrutinib) as First-Line Treatment for High-Risk Chronic Lymphocytic Leukemia jnj.com ↗
In patients treated with IMBRUVICA®-based therapy, PFS was comparable between patients with versus without specified high-risk genomic features, including del(17p)/TP53 mutated/BIRC3 mutated, the highest risk category. |
| 2020-12-06 | Janssen Research & Development, LLC | Results New Data Demonstrate Long-Term Benefit of IMBRUVICA® (ibrutinib) as First-Line Treatment for High-Risk Chronic Lymphocytic Leukemia jnj.com ↗
IMBRUVICA® pooled clinical trial analyses presented at ASH demonstrate sustained efficacy and safety in patients with historically poor outcomes |
| 2020-12-06 | AbbVie | Results 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 ↗
At 42 months, PFS rates were higher across high-risk genomic subgroups in patients treated with IMBRUVICA (63 to 82 percent) compared to those receiving chlorambucil with or without obinutuzumab (6 to 34 percent) |
| 2020-12-05 | Janssen Research & Development, LLC | Results Disease-Free Survival Data from CAPTIVATE Study Demonstrate Benefit of IMBRUVICA® (ibrutinib)-Based Regimen as Fixed Duration, First-Line Treatment for Patients with Chronic Lymphocytic Leukemia jnj.com ↗
Results from the randomized phase of the MRD Guided Cohort of the CAPTIVATE study confirm that treatment-free remissions are possible with IMBRUVICA-based fixed duration therapy, providing yet another treatment option for patients starting first-line CLL treatment. |
| 2020-12-05 | Janssen Research & Development, LLC | Results Disease-Free Survival Data from CAPTIVATE Study Demonstrate Benefit of IMBRUVICA® (ibrutinib)-Based Regimen as Fixed Duration, First-Line Treatment for Patients with Chronic Lymphocytic Leukemia jnj.com ↗ |
| 2020-12-05 | AbbVie | Results 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 ↗
The one-year disease-free survival (DFS) rate in patients randomized to placebo or ibrutinib after completing the combination regimen provides data to support a fixed-duration treatment that can offer CLL/SLL patients remission and time off treatment. |
| 2020-06-23 | AbbVie | Regulatory IMBRUVICA® (ibrutinib) Seeks to Expand U.S. Label with Long-Term Data in Waldenström's Macroglobulinemia (WM) abbvie.com ↗
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) will review a supplemental New Drug Application (sNDA) for IMBRUVICA ® (ibrutinib) in combination with rituximab for the treatment of Waldenström's macroglobulinemia (WM), a rare and incurable type of non-Hodgkin's lymphoma (NHL). |
| 2020-06-12 | ADC Therapeutics S.A. | Results ADC Therapeutics Announces Maturing Data from Pivotal Phase 2 Clinical Trial and Phase 1/2 Combination Clinical Trial of Loncastuximab Tesirine (Lonca) in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma adctherapeutics.com ↗
Interim results of the Phase 1/2 trial of Lonca in combination with ibrutinib show an encouraging overall response rate of 75.0% and complete response rate of 58.3% at the recommended Phase 2 Lonca dose |
| 2020-05-29 | BeOne Medicines | Results BeiGene Presents Updated Head to Head Results from Phase 3 Trial of Zanubrutinib vs. Ibrutinib in Patients with Waldenström’s Macroglobulinemia at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program beonemedicines.com ↗ |
| 2020-04-22 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves IMBRUVICA® (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL) jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of IMBRUVICA®(ibrutinib) in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who are new to therapy. |
| 2020-04-21 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves IMBRUVICA® (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL) jnj.com ↗ |
| 2020-04-21 | AbbVie | Regulatory IMBRUVICA® (ibrutinib) Receives 11th FDA Approval abbvie.com ↗
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 rituximab for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). |
| 2020-01-20 | Janssen Research & Development, LLC | Regulatory Janssen Seeks Expanded Use of IMBRUVICA® (ibrutinib) in Combination with Rituximab for Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL) jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) |
| 2019-12-16 | BeOne Medicines | Results BeiGene Announces Results of Phase 3 ASPEN Trial of Zanubrutinib Compared to Ibrutinib for the Treatment of Patients with Waldenström’s Macroglobulinemia beonemedicines.com ↗
today announced results from the Phase 3 ASPEN trial comparing its BTK inhibitor BRUKINSA™ (zanubrutinib) to ibrutinib for the treatment of Waldenström’s macroglobulinemia (WM). |
| 2019-12-09 | Janssen Research & Development, LLC | Results IMBRUVICA® (ibrutinib) Combination Therapy Data From Two Studies and Long-Term Integrated Analysis Presented at ASH 2019 Show Efficacy and Safety in First-Line Treatment of Chronic Lymphocytic Leukemia jnj.com ↗
Results from a 48-month follow-up analysis of the Phase 3 E1912 clinical study reported a statistically significant difference in PFS and OS for IMBRUVICA®plus rituximab compared to a standard chemoimmunotherapy regimen of fludarabine, cyclophosphamide and rituximab (FCR). |
| 2019-12-08 | Karyopharm Therapeutics Inc | Results Karyopharm Presents XPOVIO® (Selinexor) and Eltanexor Data at the American Society of Hematology 2019 Annual Meeting karyopharm.com ↗
This combination was tolerable and demonstrated encouraging efficacy in this high-unmet need patient population warranting additional future clinical investigation. |
| 2019-12-07 | AbbVie | Results 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 ↗
Patients achieving a CR with IMBRUVICA had a strong response, with a median duration of therapy longer than 5.5 years. |
| 2019-12-07 | AbbVie | Results 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 | Results Extended Follow-up Phase 3 Data Underscore Sustained Efficacy and Safety of IMBRUVICA® (ibrutinib) in the Treatment of Chronic Lymphocytic Leukemia (CLL) abbvie.com ↗
These results demonstrated the benefits of IMBRUVICA ® (ibrutinib) plus rituximab compared to a standard chemoimmunotherapy regimen of fludarabine, cyclophosphamide and rituximab (FCR) for previously untreated patients with CLL aged 70 years or younger. |
| 2019-11-08 | Janssen Research & Development, LLC | Regulatory Janssen Announces Submission of Supplemental New Drug Application to U.S. FDA Seeking Approval of IMBRUVICA® (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukemia jnj.com ↗
Janssen Announces Submission of Supplemental New Drug Application to U.S. FDA Seeking Approval of IMBRUVICA® (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukemia |
| 2019-11-08 | AbbVie | Regulatory 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 ↗
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for IMBRUVICA ® (ibrutinib) in combination with rituximab for the first-line treatment of younger patients (70 years old or younger) with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). |
| 2019-08-13 | Janssen Research & Development, LLC | Regulatory Janssen Announces European Commission Approval of Imbruvica®▼(ibrutinib) for Expanded Use in Two Indications jnj.com ↗ |
| 2019-06-28 | Janssen Research & Development, LLC | Regulatory Janssen Receives Positive CHMP Opinion Recommending Expanded Use of Imbruvica®▼(ibrutinib) in Two Indications in Europe jnj.com ↗ |
| 2019-06-03 | Janssen Research & Development, LLC | Results IMBRUVICA® (ibrutinib) Long-Term Data from Two Pivotal Phase 3 Studies at ASCO and EHA Demonstrate Sustained Efficacy and Safety in Patients with Chronic Lymphocytic Leukemia (CLL) jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced long-term follow-up results from two pivotal Phase 3 studies of IMBRUVICA®(ibrutinib) in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), a type of non-Hodgkin lymphoma and the most common form of leukemia in adults. |
| 2019-06-03 | Janssen Research & Development, LLC | Results IMBRUVICA® (ibrutinib) Long-Term Data from Two Pivotal Phase 3 Studies at ASCO and EHA Demonstrate Sustained Efficacy and Safety in Patients with Chronic Lymphocytic Leukemia (CLL) jnj.com ↗ |
| 2019-01-31 | NATCO Pharma Ltd. | Regulatory NATCO and Alvogen file ANDA for Ibrutinib Tablets for the USA market natcopharma.co.in ↗
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce its submission of an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for generic version of Ibrutinib Tablets of 140mg, 280mg, 420mg and 560mg strength (proposed generic equivalents to Imbruvica® Tablets). |
| 2019-01-28 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves IMBRUVICA® (ibrutinib) Plus Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia jnj.com ↗ |
| 2019-01-28 | AbbVie | Regulatory 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 ↗
This latest IMBRUVICA FDA approval gives the healthcare community the first chemotherapy-free, anti-CD20 combination to treat CLL and SLL patients who have not yet started therapy. |
| 2019-01-18 | AbbVie | Results AbbVie Provides Update on Phase 3 Study of Ibrutinib (IMBRUVICA®) in Metastatic Pancreatic Cancer abbvie.com ↗
At conclusion, the study did not meet its primary endpoint of improving progression-free survival (PFS) or overall survival (OS) benefit among the study population. |
| 2018-12-04 | AbbVie | Results 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 ↗
This interim analysis showed that IMBRUVICA plus rituximab significantly prolonged progression-free survival (PFS), the primary endpoint of the study, compared to FCR, with a 65 percent reduction in risk of progression or death. |
| 2018-12-03 | Janssen Research & Development, LLC | Results IMBRUVICA® (ibrutinib) Plus Obinutuzumab Showed Significant Improvement in Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma jnj.com ↗ |
| 2018-12-03 | AbbVie | Results 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 | Results 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 ↗
The updated Phase 1b /2 data demonstrated durable responses in CLL/SLL patients with an overall response rate (ORR) of 89 percent. |
| 2018-11-15 | Janssen Research & Development, LLC | Regulatory Janssen seeks expanded use of IMBRUVICA®▼ (ibrutinib) in two indications in Europe jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of two Type II variation applications to the European Medicines Agency (EMA) seeking approval for the expanded use of IMBRUVICA® (ibrutinib). |
| 2018-10-17 | AbbVie | Regulatory 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 | Regulatory 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 ↗
today announced that the U.S. Food and Drug Administration (FDA) approved IMBRUVICA ® (ibrutinib) plus rituximab (RITUXAN ® ) for the treatment of adult patients with Waldenström's macroglobulinemia (WM), a rare and incurable type of non-Hodgkin's lymphoma (NHL). |
| 2018-07-11 | Janssen Research & Development, LLC | Results Janssen Provides Update on IMBRUVICA® (ibrutinib) Phase 3 PHOENIX Trial in Newly Diagnosed Non-Germinal Center B Cell (Non-GCB) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL) jnj.com ↗
The clinical trial did not meet the primary endpoint of event -free survival in patients with non-GCB subtype of DLBCL, including activated B cell -like (ABC) subtype of DLBCL. |
| 2018-07-11 | AbbVie | Results 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 ↗
The study did not show additional efficacy when adding ibrutinib to existing standard of care, R-CHOP. |
| 2018-06-25 | AbbVie | Regulatory 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 | Results 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 ↗
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. |
| 2018-06-01 | AbbVie | Results 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 ↗
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). |
| 2018-05-24 | AbbVie | Results IMBRUVICA® (ibrutinib) Plus GAZYVA® (obinutuzumab) Phase 3 iLLUMINATE Trial for First-Line Therapy of Chronic Lymphocytic Leukemia (CLL) Patients Met Primary Endpoint abbvie.com ↗
Specifically, the study met its primary endpoint for a clinically and statistically significant difference in PFS for patients treated with IMBRUVICA plus obinutuzumab versus those who received chlorambucil plus obinutuzumab, as assessed by an Independent Review Committee (IRC). |
| 2017-12-11 | AbbVie | Results 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 ↗
New results showed ibrutinib selectively inhibited pre-germinal center B cells and follicular helper T cells (Tfh) that are believed to play a critical role in treating cGVHD. |
| 2017-12-09 | Janssen Research & Development, LLC | Results Sustained Benefit in Patients with Relapsed/Refractory Mantle Cell Lymphoma Demonstrated by 31/2-Year Follow-Up Data of IMBRUVICA® (ibrutinib) jnj.com ↗
Today, Janssen Research & Development, LLC (Janssen) announced results of a pooled analysis of relapsed/refractory (r/r) mantle cell lymphoma (MCL) patients treated with IMBRUVICA® (ibrutinib). |
| 2017-12-09 | AbbVie | Results 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 ↗
The analysis found that, at three years, 45 percent of patients were able to achieve overall survival (OS) and 26 percent had disease progression-free survival (PFS). |
| 2017-12-09 | AbbVie | Results 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 ↗
At 30 months, ibrutinib was also associated with a greater progression-free survival (PFS) rate of 85 percent versus chlorambucil, which had a PFS rate of 28 percent. |
| 2017-12-05 | Janssen Research & Development, LLC | Results Phase 3 Study Evaluating IMBRUVICA® (ibrutinib) in Combination with Rituximab in Waldenström's Macroglobulinemia Met Primary Endpoint jnj.com ↗
Janssen Research & Development, LLC (Janssen) announced that the Phase 3 iNNOVATE (PCYC-1127) study evaluating IMBRUVICA® (ibrutinib) in combination with rituximab (RITUXAN®) in relapsed/refractory and treatment-naïve patients with Waldenström’s macroglobulinemia (WM) successfully met its primary endpoint of progression-free survival (PFS). |
| 2017-12-05 | AbbVie | Results IMBRUVICA® (ibrutinib) Plus Rituximab Phase 3 iNNOVATE Trial in Rare Waldenström's Macroglobulinemia Met Primary Endpoint abbvie.com ↗
The Independent Data Monitoring Committee (IDMC) recommended that the study be unblinded based on the positive outcome from the pre-specified interim analysis data. |
| 2017-10-30 | Janssen Research & Development, LLC | Regulatory Janssen Inc. Announces IMBRUVICA® (ibrutinib) as the First Approved Treatment for Chronic Graft-Versus-Host Disease (cGVHD) Granted by Health Canada Priority Review jnj.com ↗
Janssen Inc. announced today that following Priority Review, Health Canada has approved IMBRUVICA® (ibrutinib), an oral, once-daily targeted therapy, for the treatment of patients with steroid dependent or refractory chronic graft-versus-host disease (cGVHD). |
| 2017-08-02 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves IMBRUVICA® (ibrutinib) as First and Only Approved Treatment for Adult Patients with Chronic Graft-Versus-Host-Disease (cGVHD) After Failure of One or More Lines of Systemic Therapy jnj.com ↗
U.S. FDA Approves IMBRUVICA® (ibrutinib) as First and Only Approved Treatment for Adult Patients with Chronic Graft-Versus-Host-Disease (cGVHD) After Failure of One or More Lines of Systemic Therapy |
| 2017-08-02 | AbbVie | Regulatory 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 ↗
AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) for the treatment of adult patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy. |
| 2017-06-05 | AbbVie | Results 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 ↗
At the same time, IMBRUVICA spared non-cancerous immune system cells, including naïve T cells, T memory stem cells (TSCM) and natural killer (NK) cells through one year of treatment. |
| 2017-06-05 | AbbVie | Results 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 ↗
Long-term follow-up results from the pivotal Phase 3 RESONATE™ trial (PCYC-1112) showed continued survival rates in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL) treated with IMBRUVICA (ibrutinib) up to four years, according to new data presented today at the 53 rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago (poster session: 8:00 a.m. – 11:30 a.m. CDT ; poster discussion: 1:15 p.m. – 2:30 p.m. CDT ). |
| 2017-06-05 | AbbVie | Results 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 ↗
In addition, 3-year overall survival (OS; 74 percent) was longer in IMBRUVICA-treated patients. |
| 2017-05-30 | Novartis Pharmaceuticals | Results 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 | Results 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 | Regulatory 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 ↗
a supplemental New Drug Application (sNDA) was accepted for review by the U.S. Food and Drug Administration (FDA) for ibrutinib (IMBRUVICA®) in chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy |
| 2017-01-19 | AbbVie | Regulatory 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 ↗
AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) approved IMBRUVICA® (ibrutinib) for the treatment of patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. |
| 2016-12-06 | AbbVie | Results 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 ↗
The study found ibrutinib demonstrated efficacy, sustained responses and reduced symptom severity, with an overall response rate (ORR) of 67%. |
| 2016-12-05 | AbbVie | Results New Phase 2 Data Show Nearly Half of Patients with Relapsed/Refractory Marginal Zone Lymphoma (MZL) Respond to Treatment with Ibrutinib (IMBRUVICA®) abbvie.com ↗
The median duration of response was not reached. |
| 2016-12-04 | AbbVie | Results Favorable Response Rates Suggest Promise of Ibrutinib (IMBRUVICA®) Combination Therapy in Two Common Types of Non-Hodgkin's Lymphoma abbvie.com ↗
AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced encouraging efficacy and safety findings from two separate studies evaluating ibrutinib (IMBRUVICA®) as a combination therapy in two of the most common types of non-Hodgkin's lymphoma: diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). |
| 2016-12-03 | AbbVie | Results 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 ↗
In this analysis, 89% of treatment-naïve (TN) and relapsed/refractory (R/R) patients with CLL/SLL, including those with high-risk disease, show a complete or partial response. |
| 2016-09-26 | AbbVie | Regulatory AbbVie Announces Submission of a Supplemental New Drug Application for Ibrutinib (IMBRUVICA®) for Treatment of Marginal Zone Lymphoma abbvie.com ↗
AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for ibrutinib (IMBRUVICA ® ) to treat patients with marginal zone lymphoma (MZL). |
| 2016-06-29 | Janssen Research & Development, LLC | Regulatory Ibrutinib (IMBRUVICA®) Granted Breakthrough Therapy Designation by U.S. Food and Drug Administration (FDA) for the Development of a Treatment for Chronic Graft-Versus-Host Disease (cGVHD) jnj.com ↗
The FDA also granted the therapy Orphan Drug Designation (ODD) for cGVHD. |
| 2016-06-29 | AbbVie | Regulatory 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 ↗
NORTH CHICAGO, Ill. , June 29, 2016 / PRNewswire / -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) granted a fourth Breakthrough Therapy Designation (BTD) for ibrutinib (IMBRUVICA ® ) as a potential treatment of chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy. |
| 2016-06-06 | AbbVie | Results 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 ↗
Today, AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced longer-term follow-up results from Phase 3 studies of IMBRUVICA® (ibrutinib) in chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL). |
| 2016-05-31 | Janssen Research & Development, LLC | Regulatory Janssen's IMBRUVICA®▼(ibrutinib) Approved by European Commission for Patients with Newly Diagnosed Chronic Lymphocytic Leukaemia jnj.com ↗
Janssen-Cilag International NV (Janssen) announced today that the European Commission (EC) has approved IMBRUVICA (ibrutinib) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). |
| 2016-05-31 | AbbVie | Regulatory European Commission Approves IMBRUVICA® (ibrutinib) for First-Line Treatment of Patients with Chronic Lymphocytic Leukemia abbvie.com ↗
This approval marks a number of significant landmarks for IMBRUVICA: this is the drug's fifth treatment indication in the EU and this approval means that IMBRUVICA is now available to treat all lines of CLL in the EU. |
| 2016-05-09 | Janssen Research & Development, LLC | Regulatory FDA Expands IMBRUVICA Label to Include New Data from Two Key Phase 3 Trials, Adding Overall Survival and Combination Data jnj.com ↗
The U.S. Food and Drug Administration (FDA) has approved an expansion to the IMBRUVICA (ibrutinib) U.S. Prescribing Information (PI) based on data supporting its use in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Janssen announced today. |
| 2016-05-09 | AbbVie | Regulatory 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 ↗
As well, following a review of the November 2015 supplemental New Drug Application (sNDA), the FDA has approved a new IMBRUVICA indication to include the treatment of patients with SLL with or without the deletion of chromosome 17p (del 17p). |
| 2016-04-29 | Janssen Research & Development, LLC | Regulatory Janssen's IMBRUVICA® (ibrutinib) Receives Positive CHMP Opinion for Expanded Use in Previously Untreated Chronic Lymphocytic Leukaemia Patients jnj.com ↗
Janssen's IMBRUVICA® (ibrutinib) Receives Positive CHMP Opinion for Expanded Use in Previously Untreated Chronic Lymphocytic Leukaemia Patients |
| 2016-04-29 | AbbVie | Regulatory European Medicines Agency Issues Positive Opinion for the Use of IMBRUVICA® (ibrutinib) as a First-Line Treatment for Chronic Lymphocytic Leukemia Patients abbvie.com ↗
AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion in favor of the use of IMBRUVICA® (ibrutinib) for the treatment of adult patients with previously-untreated chronic lymphocytic leukemia (CLL) in the European Union (EU). |
| 2016-03-04 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves IMBRUVICA® (ibrutinib) for First-line Treatment of Chronic Lymphocytic Leukemia jnj.com ↗
The U.S. Food and Drug Administration (FDA) has approved IMBRUVICA (ibrutinib) capsules for treatment-naïve patients with chronic lymphocytic leukemia (CLL). |
| 2016-03-04 | AbbVie | Regulatory IMBRUVICA® (ibrutinib) Approved by U.S. FDA for the First-line Treatment of Chronic Lymphocytic Leukemia abbvie.com ↗
AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) approved IMBRUVICA ® (ibrutinib) as a first-line treatment for patients with chronic lymphocytic leukemia (CLL). |
| 2015-12-07 | AbbVie | Results IMBRUVICA® (Ibrutinib) Phase 3 RAY Data Show Significant Reductions in Disease Progression versus Temsirolimus in Relapsed/Refractory Mantle Cell Lymphoma Patients abbvie.com ↗
Notably, IMBRUVICA was associated with a 57% reduction in the risk of progression or death with a median follow-up of 20 months. |
| 2015-12-07 | AbbVie | Results Combination Ibrutinib (IMBRUVICA®) Demonstrates a Strong Response Rate in Treatment-Naive Patients with Follicular Lymphoma abbvie.com ↗
Today, AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced Phase 2 data demonstrated that the combination of ibrutinib (IMBRUVICA ® ) plus rituximab was well tolerated and associated with an overall response rate of 82%, (ORR; the primary endpoint of the study), in treatment-naive patients with follicular lymphoma (FL). |
| 2015-12-06 | AbbVie | Results Ibrutinib (IMBRUVICA®) Improves Survival in Treatment-Naive Chronic Lymphocytic Leukemia Patients in the Phase 3 RESONATE™-2 Trial abbvie.com ↗
ibrutinib (IMBRUVICA ® ) significantly decreased the risk of progression or death (progression-free survival, PFS; the primary endpoint) and significantly decreased the risk of death (overall survival, OS; a key secondary endpoint) versus chemotherapy (chlorambucil) |
| 2015-12-06 | AbbVie | Results Ibrutinib (IMBRUVICA®) Combination Data Show Promise in Patients with Relapsed/Refractory Multiple Myeloma abbvie.com ↗
Thirty-nine patients were evaluable for efficacy and demonstrated a 62% ORR during early follow-up, with a clinical benefit rate (CBR) of 72%. |
| 2015-11-13 | Janssen Research & Development, LLC | Regulatory Additional Efficacy and Safety Data for IMBRUVICA® (Ibrutinib) Submitted to FDA jnj.com ↗
Pharmacyclics is the investigational new drug (IND) holder for IMBRUVICA in the U.S. and submitted the application to the FDA on behalf of the companies. |
| 2015-11-13 | AbbVie | Regulatory AbbVie Submits IMBRUVICA® (ibrutinib) Phase III Combination Data to U.S. FDA abbvie.com ↗
announced today that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) |
| 2015-10-30 | Janssen Research & Development, LLC | Regulatory Janssen Submits Application to the EMA to Expand Use of IMBRUVICA® (ibrutinib) in Previously Untreated Chronic Lymphocytic Leukaemia Patients jnj.com ↗
Janssen-Cilag International NV announced today the submission of a Type II variation application to the European Medicines Agency (EMA) seeking to broaden the existing marketing authorisation for IMBRUVICA® (ibrutinib) to include previously untreated patients with chronic lymphocytic leukaemia (CLL). |
| 2015-09-14 | Janssen Research & Development, LLC | Regulatory IMBRUVICA® (ibrutinib) Supplemental New Drug Application for Treatment-naïve Chronic Lymphocytic Leukemia Submitted to the U.S. FDA jnj.com ↗
A supplemental New Drug Application (sNDA) for IMBRUVICA (ibrutinib) has been submitted to the U.S. Food and Drug Administration (FDA) for front-line use in patients with chronic lymphocytic leukemia (CLL), Janssen Biotech Inc. announced today. |
| 2015-09-14 | AbbVie | Regulatory AbbVie Announces Submission of a Supplemental New Drug Application for IMBRUVICA® (ibrutinib) for Treatment-Naive Chronic Lymphocytic Leukemia abbvie.com ↗ |
| 2015-07-10 | Janssen Research & Development, LLC | Regulatory Janssen's IMBRUVICA®▼(ibrutinib) Receives Additional European Commission Approval for the Treatment of Waldenström's Macroglobulinemia jnj.com ↗ |
| 2015-07-10 | AbbVie | Regulatory IMBRUVICA® (ibrutinib) Now Approved to Treat Waldenstrom's Macroglobulinemia in Europe abbvie.com ↗
The approval of IMBRUVICA to treat patients with WM triggers a $20 million milestone payment from Janssen. |
| 2015-05-30 | Janssen Research & Development, LLC | Results Ibrutinib (IMBRUVICA®) HELIOS Interim Analysis Study Data Show Significant Reductions in Risk of Progression or Death in Patients with Previously-Treated Chronic Lymphocytic Leukemia jnj.com ↗ |
| 2015-05-21 | Janssen Research & Development, LLC | Regulatory Janssen Receives Positive CHMP Opinion Recommending IMBRUVICA® (ibrutinib) for the Treatment of Waldenström's Macroglobulinemia jnj.com ↗
Janssen Receives Positive CHMP Opinion Recommending IMBRUVICA® (ibrutinib) for the Treatment of Waldenström's Macroglobulinemia |
| 2015-03-16 | Janssen Research & Development, LLC | Results Phase 3 Study with IMBRUVICA® (ibrutinib) Combination Demonstrates Significant Delay in Disease Progression jnj.com ↗ |
| 2015-01-29 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves IMBRUVICA® (ibrutinib) for the Treatment of Waldenström's Macroglobulinemia: First FDA-Approved Therapy for This Disease jnj.com ↗ |
| 2014-12-08 | Janssen Research & Development, LLC | Results IMBRUVICA® (ibrutinib) Shows Sustained Progression-Free Survival in Patients with High-Risk Chronic Lymphocytic Leukemia with Genetic Mutation jnj.com ↗
IMBRUVICA® (ibrutinib) Shows Sustained Progression-Free Survival in Patients with High-Risk Chronic Lymphocytic Leukemia with Genetic Mutation |
| 2014-12-08 | Janssen Research & Development, LLC | Results IMBRUVICA® (ibrutinib) Long-term Follow-up Data in Patients Living with Relapsed/Refractory Mantle Cell Lymphoma Show Almost Half Alive at Two Years jnj.com ↗
IMBRUVICA was associated with a 67 percent investigator-assessed overall response rate (ORR) with a median progression-free survival (PFS) of 13 months. |
| 2014-12-01 | Janssen Research & Development, LLC | Regulatory Application Submitted To The EMA To Expand The Therapeutic Indication For IMBRUVICA® (ibrutinib) To Include Treatment Of Waldenström's Macroglobulinemia jnj.com ↗
Application Submitted To The EMA To Expand The Therapeutic Indication For IMBRUVICA® (ibrutinib) To Include Treatment Of Waldenström's Macroglobulinemia |
| 2014-11-19 | Janssen Research & Development, LLC | Regulatory Health Canada Approves IMBRUVICA™ by Priority Review, Giving Physicians and Patients a Much-Needed Option in the Fight Against Chronic Lymphocytic Leukemia jnj.com ↗
Janssen Inc. announced today Health Canada has approved IMBRUVICATM (ibrutinib) for the treatment of the blood cancer chronic lymphocytic leukemia (CLL). |
| 2014-10-20 | Janssen Research & Development, LLC | Regulatory IMBRUVICA® (ibrutinib) Supplemental New Drug Application Submitted to the U.S. FDA for Waldenström's macroglobulinemia jnj.com ↗
Janssen Research & Development, LLC ("Janssen") today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA® (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its strategic partner Pharmacyclics, Inc. |
| 2014-10-17 | Janssen Research & Development, LLC | Regulatory European Commission Approves IMBRUVICATM in Two Forms of Blood Cancer jnj.com ↗
This approval allows for the marketing of IMBRUVICA in all 28 countries of the European Union. |
| 2014-07-28 | Janssen Research & Development, LLC | Regulatory IMBRUVICA® (ibrutinib) Receives Regular Approval by U.S. FDA in Chronic Lymphocytic Leukemia (CLL) and CLL patients with del 17p jnj.com ↗
The U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for IMBRUVICA® (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. |
| 2014-07-25 | Janssen Research & Development, LLC | Regulatory Janssen Receives Positive CHMP Opinion Recommending IMBRUVICA™ for use in the Treatment of Two Forms of Blood Cancer jnj.com ↗
Janssen Receives Positive CHMP Opinion Recommending IMBRUVICA™ for use in the Treatment of Two Forms of Blood Cancer |
| 2014-05-31 | Janssen Research & Development, LLC | Results Ibrutinib (IMBRUVICA®) Three Year Follow-up of Single-Agent and Combination Study Results in Chronic Lymphocytic Leukemia jnj.com ↗
Janssen Research & Development, LLC, announced the results today, which show ibrutinib continued to produce high overall response rates (ORR) (78 percent for all treated patients, with the median duration of response not achieved after almost 30 months). |
| 2014-04-08 | Janssen Research & Development, LLC | Regulatory Supplemental New Drug Application for IMBRUVICATM (ibrutinib) Submitted to the U.S. FDA jnj.com ↗
Janssen Research & Development, LLC ("Janssen") today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICATM™ (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc. |
| 2014-02-12 | Janssen Research & Development, LLC | Regulatory IMBRUVICA™ (ibrutinib) Now Approved in the U.S. for Patients with Chronic Lymphocytic Leukemia Who Have Received At Least One Prior Therapy jnj.com ↗
Janssen Biotech, Inc. ["Janssen"] today announced the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA™ (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. |
| 2014-01-07 | Janssen Research & Development, LLC | Results Independent Data Monitoring Committee Recommends Early Stopping of Phase 3 Study of Ibrutinib in Relapsed/Refractory CLL/SLL Patients Based on a Planned Interim Analysis jnj.com ↗
Independent Data Monitoring Committee Recommends Early Stopping of Phase 3 Study of Ibrutinib in Relapsed/Refractory CLL/SLL Patients Based on a Planned Interim Analysis |
| 2013-12-10 | Janssen Research & Development, LLC | Results Ibrutinib Data Published in The Lancet Oncology Suggest a Positive Effect in Previously Untreated Chronic Lymphocytic Leukemia Patients Over Age 65 jnj.com ↗
The study met its primary endpoint of safety, with data demonstrating treatment with ibrutinib as an initial therapy was associated with adverse events (AEs) that were predominantly Grade 1 or 2 in nature. |
| 2013-11-19 | Janssen Research & Development, LLC | Results Janssen Oncology Data to be Presented at 2013 American Society of Hematology (ASH) Annual Meeting jnj.com ↗
Ibrutinib in combination with bendamustine and rituximab is active and tolerable in patients with relapsed/refractory CLL/SLL: final results of a phase 1b study. |
| 2013-11-13 | Janssen Research & Development, LLC | Regulatory IMBRUVICA™ (ibrutinib) Capsules Now Approved in the U.S. for Mantle Cell Lymphoma Patients Who Have Received at Least One Prior Therapy jnj.com ↗
Janssen Biotech, Inc. [“Janssen”] today announced the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA™ (ibrutinib) capsules for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. |
| 2013-10-30 | Janssen Research & Development, LLC | Regulatory New Marketing Authorisation Application Submitted to EMA for Ibrutinib for the Treatment of Two Forms of Blood Cancer jnj.com ↗
Janssen-Cilag International NV (Janssen) announced today it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ibrutinib for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) or relapsed or refractory mantle cell lymphoma (MCL), two forms of blood cancer. |
| 2013-07-10 | Janssen Research & Development, LLC | Regulatory New Drug Application Submitted to U.S. FDA for Ibrutinib in the Treatment of Two B-Cell Malignancies jnj.com ↗
Janssen Research & Development, LLC announced the submission of a New Drug Application for ibrutinib to the U.S. Food and Drug Administration (FDA) for its use in the treatment of previously treated patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and for its use in the treatment of previously treated patients with mantle cell lymphoma (MCL). |
| 2013-06-19 | Janssen Research & Development, LLC | Results Ibrutinib Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Data Published in The New England Journal of Medicine jnj.com ↗
Results from a Phase 1b/2 study show that ibrutinib is well tolerated and produced durable responses at both dose levels studied in patients with relapsed/refractory CLL or small lymphocytic lymphoma (SLL). |
| 2013-06-19 | Janssen Research & Development, LLC | Results Ibrutinib Data Published in The New England Journal of Medicine Show jnj.com ↗
The response to ibrutinib did not vary based on prior exposure to bortezomib. |
| 2013-06-16 | Janssen Research & Development, LLC | Results Updated Results of Two Phase 2 ibrutinib Studies in Patients with Mantle Cell Lymphoma or Diffuse Large B-cell Lymphoma jnj.com ↗
Ibrutinib was shown to achieve the following key results among patients with relapsed/refractory MCL: |
| 2013-04-08 | Janssen Research & Development, LLC | Regulatory Ibrutinib Receives Third Oncology Breakthrough Therapy Designation from U.S. Food and Drug Administration jnj.com ↗
Janssen Research & Development, LLC ( Janssen) announced today that the U.S. Food and Drug Administration (FDA) has granted a third Breakthrough Therapy Designation for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor ibrutinib. |
| 2013-02-12 | Janssen Research & Development, LLC | Regulatory Ibrutinib Receives Two Oncology Breakthrough Therapy Designations from U.S. Food and Drug Administration jnj.com ↗ |
All press releases naming this drug 201 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 201 releases opens the full record — a long page | ||
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 ↗336“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 ↗ |
| 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 ↗1“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 ↗ |
| 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 |