Drugs / Bendamustine
Bendamustine
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed indolent B-cell non-Hodgkin lymphoma 2 milestones | |||||
| Filed | US (FDA) | — | indolent B-cell non-Hodgkin lymphoma | 2015-04-30 | “Eagle's NDA for a liquid bendamustine hydrochloride rapid infusion product, for which Teva has an exclusive license, was accepted for filing by the FDA.” tevapharm.com ↗ |
| Filed | US (FDA) | — | indolent B-cell non-Hodgkin lymphoma | 2015-02-17 | “today announce that the New Drug Application (NDA) for a liquid bendamustine hydrochloride (HCl) rapid infusion product has been accepted for filing by the U.S. Food and Drug...” tevapharm.com ↗ |
| Approved Indication not stated 5 milestones | |||||
| Filed | Other | Innomustine | indolent non-Hodgkin lymphoma, chronic lymphocytic leukemia, multiple myeloma | 2010-02-06 | “it has submitted a New Drug Application (NDA) to the Taiwan Food and Drug Administration (TFDA) for the approval of Innomustine® (bendamustine HCl).” innopharmax.com ↗ |
| Filed | Other | Symbenda | low-grade non-Hodgkin lymphoma, chronic lymphocytic leukemia | 2008-12-24 | “A regulatory application seeking approval of bendamustine was submitted to the Singapore health authorities (Health Sciences Authority: HSA) by SymBio on December 24, 2008” eisai.com ↗ |
| Approved | US (FDA) | TREANDA | — | 2008-03-20 | fda.gov ↗ |
| Filed | EU (EMA) | — | chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma | — | “Bendamustine was filed a marketing application, via the decentralized procedure, in EMEA and approved for indications of CLL, NHL, and multiple myeloma in July, 2010.” innopharmax.com ↗ |
| Filed | Japan (PMDA) | — | low-grade non-Hodgkin lymphoma, mantle cell lymphoma | — | “SymBio submitted a Marketing Authorization Application to the Japanese Ministry of Health, Labour and Welfare seeking approval of bendamustine” eisai.com ↗ |
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News releases announcing trial results or a regulatory action · 57
| Date | Issuer | Release |
|---|---|---|
| 2026-09-09 | Fate Therapeutics | Results Fate Therapeutics Announces Encore Clinical Data Presentation of FT819 Off-the-Shelf CAR T-Cell Product Candidate at the CCR – West 2026 Meeting fatetherapeutics.com ↗ |
| 2026-06-11 | BeOne Medicines | Results BeOne Showcases Landmark Phase 3 Data in CLL Patients Aged 80+ at EHA 2026, Reinforcing BRUKINSA Benefit beonemedicines.com ↗
The subgroup analysis will be presented alongside the 78-month SEQUOIA dataset, the longest reported follow-up for a next-generation BTK inhibitor in first-line CLL, showing a 78-month PFS of 71.8% for BRUKINSA versus 31.0% for bendamustine-rituximab. |
| 2026-05-29 | BeOne Medicines | Results BeOne Medicines Establishes Standard for Long-Term Disease Control in CLL with BRUKINSA 78-Month Data at ASCO 2026 beonemedicines.com ↗
After a median follow-up of 84.01 months (range, 0.0-101.5), BRUKINSA continued to show benefit over bendamustine-rituximab (BR) in patients with treatment-naive CLL/SLL, with progression-free survival (PFS) outcomes that are unprecedented among BTK inhibitors. |
| 2025-11-03 | Genmab | Results Genmab to Showcase Latest Blood Cancer Treatment Advancements at 2025 American Society of Hematology (ASH) Annual Meeting genmab.com ↗
Vitolo et al., Fixed-duration epcoritamab in combination with bendamustine + rituximab (BR) for first-line (1L) treatment of follicular lymphoma (FL): 3-year results from EPCORE NHL-2 arm 3 demonstrate deep and durable responses with manageable safety |
| 2025-05-06 | AstraZeneca | Regulatory Calquence plus chemoimmunotherapy approved in the EU as first and only BTK inhibitor for 1st-line mantle cell lymphoma astrazeneca.com ↗
AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been approved in the European Union (EU) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant. |
| 2025-03-31 | AstraZeneca | Regulatory Calquence plus chemoimmunotherapy recommended for approval in the EU by CHMP as first and only BTK inhibitor for 1st-line mantle cell lymphoma astrazeneca.com ↗
AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been recommended for approval in the European Union (EU) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous hematopoietic stem cell transplantation. |
| 2025-01-17 | AstraZeneca | Regulatory Calquence plus chemoimmunotherapy approved in the US for patients with previously untreated mantle cell lymphoma astrazeneca.com ↗
AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been approved in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. |
| 2024-11-05 | BeOne Medicines | Results BeiGene Highlights Innovative Hematology Portfolio Across B-cell Malignancies at ASH 2024 beonemedicines.com ↗
Sustained superiority of zanubrutinib vs bendamustine + rituximab in treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (TN CLL): 5-year follow-up of cohort 1 from the SEQUOIA study |
| 2024-06-16 | AstraZeneca | Results Calquence plus chemoimmunotherapy reduced the risk of disease progression or death by 27% vs. standard of care in patients with untreated mantle cell lymphoma in ECHO Phase III trial astrazeneca.com ↗
Results showed the Calquence combination regimen reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy (hazard ratio [HR] 0.73; 95% confidence interval [CI] 0.57-0.94; p=0.016). |
| 2024-05-02 | AstraZeneca | Results Calquence combination regimen demonstrated statistically significant and clinically meaningful improvement in progression-free survival in 1st-line mantle cell lymphoma in ECHO Phase III trial astrazeneca.com ↗ |
| 2023-11-28 | BeOne Medicines | Results BeiGene to Present New Data Highlighting Hematology Portfolio and Pipeline Strengths at ASH 2023 beonemedicines.com ↗
Broad Superiority of Zanubrutinib Over Bendamustine + Rituximab Across Multiple High-Risk Factors: Biomarker Subgroup Analysis in the Phase 3 SEQUOIA Study in Patients with Treatment-Naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma without del(17p) |
| 2023-06-09 | AbbVie | Results AbbVie's VENCLYXTO®/VENCLEXTA® (venetoclax) Continues to Show Sustained Progression-Free Survival (PFS) in Chronic Lymphocytic Leukemia (CLL) Patients abbvie.com ↗
Final seven-year follow-up results of the Phase 3 MURANO trial demonstrate sustained PFS and overall survival (OS) with venetoclax and rituximab compared to bendamustine and rituximab in patients with relapsed/refractory (R/R) CLL |
| 2022-06-10 | BeOne Medicines | Results BeiGene Highlights Growing Portfolio and Pipeline Targeting Hematologic Malignancies at European Hematology Association 2022 Congress beonemedicines.com ↗
In the SEQUOIA trial of zanubrutinib vs. bendamustine plus rituximab (BR), zanubrutinib was associated with significant improvements in HRQoL in patients with treatment-naïve (TN) CLL/SLL without del(17p), as indicated by patient reported outcome (PRO) endpoints. |
| 2022-06-04 | AstraZeneca | Results Calquence plus obinutuzumab demonstrated sustained survival benefit in 1st-line chronic lymphocytic leukaemia with 90% of patients surviving five years in ELEVATE-TN trial astrazeneca.com ↗
At 42 months, an estimated 62% of patients treated with Calquence were alive and had not progressed in comparison with 19% of patients treated with IdR/BR. |
| 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 |
| 2020-12-07 | Hoffmann-La Roche | Results New data presented at ASH 2020 reinforces the benefit/risk profile of fixed-duration Polivy plus bendamustine and MabThera/Rituxan in patients with relapsed or refractory diffuse large B-cell lymphoma roche.com ↗
Furthermore, new data from an extension cohort showed a CR rate of 38.7% (n=41/106) with Polivy plus BR. |
| 2020-12-05 | Hoffmann-La Roche | Results Roche announces new data reinforcing the long-term benefit of Venclexta/Venclyxto-based combination for people with relapsed or refractory chronic lymphocytic leukaemia roche.com ↗
Venclexta/Venclyxto plus MabThera/Rituxan reduced the risk of disease progression or death by 81% (HR= 0.19; 95% CI: 0.15, 0.26; p<0.0001) compared to bendamustine plus MabThera/Rituxan (BR) in people with relapsed or refractory (R/R) CLL. |
| 2020-12-05 | Genentech, Inc. | Results Genentech Announces New Data Reinforcing the Long-Term Benefit of Venclexta-Based Combination for People With Relapsed or Refractory Chronic Lymphocytic Leukemia gene.com ↗
Venclexta plus Rituxan reduced the risk of disease progression or death by 81% (HR=0.19; 95% CI: 0.15, 0.26; p<0.0001) compared to bendamustine plus Rituxan (BR) in people with relapsed or refractory (R/R) CLL. |
| 2020-12-05 | AbbVie | Results AbbVie Presents Extended Follow-Up Data for Fixed Duration Treatment VENCLEXTA®/VENCLYXTO® (venetoclax) in Chronic Lymphocytic Leukemia (CLL) abbvie.com ↗
Patients with relapsed or refractory (R/R) CLL on fixed duration VenR had a median PFS of 53.6 months (95% CI: 48.4-57.0) compared to 17.0 months (95% CI: 15.5-21.7) with bendamustine plus rituximab (BR; HR 0.1 |
| 2019-12-08 | Hoffmann-La Roche | Results New data demonstrate the continued clinical benefit of fixed-duration, chemotherapy-free Venclexta/Venclyxto-based treatments in chronic lymphocytic leukaemia roche.com ↗
Four-year, follow-up data from the study showed sustained OS and PFS benefits with Venclexta/Venclyxto plus MabThera/Rituxan compared to bendamustine plus MabThera/Rituxan (BR). |
| 2019-12-08 | Genentech, Inc. | Results New Data Demonstrate the Continued Clinical Benefit of Fixed-duration, Chemotherapy-free Venclexta-based Treatments in Chronic Lymphocytic Leukemia gene.com ↗
Four-year, follow-up data from the study showed sustained OS and PFS benefits with Venclexta plus Rituxan compared to bendamustine plus Rituxan (BR). |
| 2019-06-10 | Genentech, Inc. | Regulatory FDA Grants Genentech’s Polivy Accelerated Approval for People With Previously Treated Aggressive Lymphoma gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Polivy™ (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan® (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least two prior therapies. |
| 2018-12-04 | Hoffmann-La Roche | Results New Venclexta/Venclyxto data demonstrate deep responses in two of the most common types of leukaemia roche.com ↗
An analysis showed the combination reduced the risk of disease progression or death (progression-free survival; PFS, as assessed by investigator) by 84% (HR=0.16; 95% CI: 0.12-0.23; p<0.0001) compared to standard of care bendamustine plus MabThera/Rituxan (BR) after a median three-year follow-up. |
| 2018-12-03 | Hoffmann-La Roche | Results Longer-term follow-up data demonstrate sustained benefit of polatuzumab vedotin-based treatment in relapsed or refractory diffuse large B-cell lymphoma roche.com ↗
Polatuzumab vedotin in combination with MabThera/Rituxan (rituximab) plus bendamustine more than doubled overall survival, compared to MabThera/Rituxan plus bendamustine alone in the phase Ib/II GO29365 study |
| 2018-12-03 | Genentech, Inc. | Results New Venclexta® Data Demonstrate Deep Responses in Two of the Most Common Types of Leukemia gene.com ↗
At three years, 71 percent of patients in the Venclexta plus Rituxan arm had not experienced disease progression, compared to 15 percent of patients in the BR arm (median PFS: not reached vs. 17.0 months, respectively). |
| 2018-12-01 | AbbVie | Results AbbVie Presents New Data from Phase 3 MURANO Trial of VENCLEXTA®/VENCLYXTO® (venetoclax) in Combination with Rituximab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia Who Completed the Fixed Treatment Course abbvie.com ↗
At the time of analysis, the overall survival (OS) benefit estimated at three years was approximately 10 percent higher in the VenR arm (87.9 percent) than in the BR arm (79.5 percent) (HR: 0.50; 95% CI: 0.30, 0.85). |
| 2017-12-12 | Hoffmann-La Roche | Results Roche announces phase III data showing Venclexta/Venclyxto plus MabThera/Rituxan reduced the risk of disease progression or death by 83% compared to a standard of care regimen in previously treated chronic lymphocytic leukaemia roche.com ↗
The results showed that a fixed duration of treatment with Venclexta/Venclyxto plus MabThera/Rituxan significantly reduced the risk of disease progression or death (progression-free survival; PFS, as assessed by investigator) by 83% compared with BR (HR=0.17; 95% CI 0.11-0.25; p<0.0001). |
| 2017-12-12 | Genentech, Inc. | Results Genentech Announces Phase III Data Showing Venclexta plus Rituxan Reduced the Risk of Disease Progression or Death by 83 Percent Compared to a Standard of Care Regimen in Previously Treated Chronic Lymphocytic Leukemia gene.com ↗
This chemotherapy-free combination showed improvements across multiple efficacy measures compared to bendamustine plus Rituxan in the pivotal MURANO trial |
| 2017-12-12 | AbbVie | Results AbbVie Announces Phase 3 Study of VENCLEXTA™/ VENCLYXTO™ (venetoclax) in Combination with Rituxan® (rituximab) Meets its Primary Endpoint abbvie.com ↗
Twenty-four month PFS estimates were 84.9 percent and 36.3 percent, respectively. |
| 2017-12-10 | Hoffmann-La Roche | Results Phase II data showed Roche’s investigational polatuzumab vedotin plus bendamustine and MabThera/Rituxan (BR) increased complete response rates compared to BR alone in previously treated aggressive lymphoma roche.com ↗ |
| 2017-12-10 | Genentech, Inc. | Results Phase II Data Showed Genentech’s Investigational Polatuzumab Vedotin Plus Bendamustine and Rituxan (BR) Increased Complete Response Rates Compared to BR Alone in Previously Treated Aggressive Lymphoma gene.com ↗
Phase II Data Showed Genentech’s Investigational Polatuzumab Vedotin Plus Bendamustine and Rituxan (BR) Increased Complete Response Rates Compared to BR Alone in Previously Treated Aggressive Lymphoma |
| 2017-09-18 | Hoffmann-La Roche | Results Phase III data showed that Venclexta/Venclyxto plus MabThera/Rituxan helped people with previously treated chronic lymphocytic leukaemia live longer without their disease worsening compared to bendamustine plus MabThera/Rituxan roche.com ↗ |
| 2017-09-18 | Genentech, Inc. | Results Phase III Data Showed That Venclexta Plus Rituxan Helped People With Previously Treated Chronic Lymphocytic Leukemia Live Longer Without Their Disease Worsening Compared to Bendamustine Plus Rituxan gene.com ↗ |
| 2017-06-23 | Hoffmann-La Roche | Results Roche presents new data from GALLIUM study reinforcing clinical benefit of Gazyva/Gazyvaro in people with previously untreated follicular lymphoma roche.com ↗
A subanalysis by chemotherapy regimen showed that improvement in investigator-assessed PFS was superior for Gazyva/Gazyvaro-based treatment vs MabThera/Rituxan-based treatment across CHOP, CVP and bendamustine chemotherapy regimens. |
| 2016-11-03 | Hoffmann-La Roche | Results Roche showcases new clinical data across a variety of blood diseases at American Society of Hematology 2016 Annual Meeting roche.com ↗
Obinutuzumab Plus Bendamustine Followed By Obinutuzumab Maintenance Prolongs Overall Survival Compared With Bendamustine Alone in Patients with Rituximab-Refractory Indolent Non-Hodgkin Lymphoma: Updated Results of the GADOLIN Study |
| 2016-11-02 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory CMS Establishes Unique J-Code for BENDEKA® (Bendamustine Hydrochloride) Injection tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) announced today that the Centers for Medicare & Medicaid Services (CMS) has established a unique, product-specific billing code, or J-code (J9034), for BENDEKA® (bendamustine hydrochloride) Injection. |
| 2016-08-26 | Eisai Inc. | Regulatory ANTICANCER AGENT “TREAKISYM® FOR INJECTION 100 MG” APPROVED IN JAPAN FOR ADDITIONAL INDICATION OF CHRONIC LYMPHOCYTIC LEUKEMIA eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the anticancer agent TREAKISYM® for Injection 100 mg (generic name: bendamustine hydrochloride, “TREAKISYM”) has been approved in Japan for an additional indication of chronic lymphocytic leukemia. |
| 2016-06-16 | Hoffmann-La Roche | Regulatory Roche's Gazyvaro approved in Europe in combination with bendamustine for people with previously treated follicular lymphoma roche.com ↗ |
| 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 ↗
IMBRUVICA in combination with bendamustine and rituximab (BR) continued to demonstrate superiority over time versus placebo plus BR in relapsed/refractory CLL/SLL patients |
| 2016-04-29 | Hoffmann-La Roche | Regulatory CHMP recommends EU approval of Roche’s Gazyvaro for people with previously treated follicular lymphoma roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Gazyvaro® (obinutuzumab) in combination with bendamustine chemotherapy followed by Gazyvaro maintenance as a new treatment for people with follicular lymphoma who did not respond to, or who progressed during or up to six months after treatment with MabThera® (rituximab) or a MabThera-containing regimen. |
| 2015-12-08 | Gilead Sciences | Results Phase 3 Results for Zydelig® With Bendamustine and Rituximab for Relapsed Chronic Lymphocytic Leukemia (CLL) Presented at American Society of Hematology Annual Meeting gilead.com ↗
Gilead Sciences , Inc. (Nasdaq: GILD) today announced results from a prespecified interim analysis of a Phase 3 study (Study 115) evaluating Zydelig ® (idelalisib) in combination with bendamustine and rituximab (BR) for patients with previously treated CLL. |
| 2015-12-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Pharmaceuticals and Eagle Pharmaceuticals Announce FDA Approval of BENDEKA™ (bendamustine hydrochloride) Injection tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) today announce that the U.S. Food and Drug Administration (FDA) has approved BENDEKA™, (bendamustine hydrochloride) injection, a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine. |
| 2015-12-05 | Genentech, Inc. | Results New Results from CLL11 Study Show Gazyva® Provided People with Previously Untreated Chronic Lymphocytic Leukemia a Treatment-free Period of Nearly Four Years gene.com ↗
In addition, nearly 80 percent of people responded to treatment with Gazyva plus bendamustine (overall response rate, ORR), and a third of people (32.3 percent) achieved a complete response (CR). |
| 2015-11-16 | Gilead Sciences | Results Gilead’s Zydelig® Combined with Bendamustine and Rituximab Shows Superior Efficacy to Bendamustine/Rituximab in Phase 3 Study of Patients with Relapsed Chronic Lymphocytic Leukemia gilead.com ↗ |
| 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 ↗ |
| 2015-05-30 | Genentech, Inc. | Results Genentech’s Gazyva® Extended the Time People with Refractory Indolent Non-Hodgkin’s Lymphoma Lived Without Their Disease Worsening gene.com ↗
In the study, Gazyva plus bendamustine followed by Gazyva alone reduced the risk of disease worsening or death (progression-free survival, PFS) by 45 percent (HR=0.55, p=0.0001), compared to bendamustine alone. |
| 2015-04-14 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva and Eagle Pharmaceuticals Announce NDA for Bendamustine Rapid Infusion Product Accepted for Filing tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) today announce that the New Drug Application (NDA) for a liquid bendamustine hydrochloride (HCl) rapid infusion product has been accepted for filing by the U.S. Food and Drug Administration (FDA). |
| 2015-03-16 | Janssen Research & Development, LLC | Results Phase 3 Study with IMBRUVICA® (ibrutinib) Combination Demonstrates Significant Delay in Disease Progression jnj.com ↗ |
| 2015-02-03 | Genentech, Inc. | Results Genentech’s Phase III Study of Gazyva® Showed Significant Benefit in Refractory Indolent Non-Hodgkin’s Lymphoma gene.com ↗
The study showed that people lived significantly longer without disease worsening or death (progression-free survival; PFS) when treated with Gazyva (obinutuzumab) plus bendamustine followed by Gazyva alone, compared to bendamustine alone. |
| 2013-11-27 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Additional Regulatory Exclusivity for TREANDA® (Bendamustine HCI) for Injection tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug exclusivity for TREANDA through October 2015 for indolent B-cell non-Hodgkin lymphoma (iNHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. |
| 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. |
| 2013-09-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory FDA Approves Teva’s TREANDA® (bendamustine HCI) Injection, a New Liquid Formulation tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) approved TREANDA (bendamustine HCI) Injection, a new formulation of the currently approved TREANDA (bendamustine HCI) for Injection. |
| 2013-03-15 | Eisai Inc. | Regulatory SYMBIO AND EISAI ANNOUNCE REMOVAL OF TREAKISYM® INJECTION 100 MG ALL CASES SURVEILLANCE CONDITION FOR JAPAN MARKETING APPROVAL eisai.com ↗
Based on this analysis, MHLW concluded that post-marketing surveillance had been conducted properly with necessary measures for proper use of the drug in place, and accordingly, no further surveillance is required. |
| 2011-10-24 | InnoPharmax Inc. | Regulatory InnoPharmax announced the NDA approval of Innomustine®Injection in Taiwan innopharmax.com ↗ |
| 2010-10-27 | Eisai Inc. | Regulatory EISAI ANNOUNCES JAPAN APPROVAL OF ANTICANCER AGENT TREAKISYM® eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that the anticancer agent TREAKISYM® (generic name: bendamustine hydrochloride) has received marketing approval in Japan for the treatment of relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma and mantle cell lymphoma. |
| 2010-02-06 | InnoPharmax Inc. | Regulatory InnoPharmax Submits NDA for Innomustine® for the Treatment of Patients with Indolent NHL, CLL and MM innopharmax.com ↗
InnoPharmax announced that it has submitted a New Drug Application (NDA) to the Taiwan Food and Drug Administration (TFDA) for the approval of Innomustine® (bendamustine HCl). |
All press releases naming this drug 67 releases
Evidence & citations 21 cited values
Every value below carries the sentence it was read from. 401 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bendamustine | “This is a phase 1/2 open label study to assess the safety and efficacy of pixantrone in combination with bendamustine, etoposide and , for CD20 positive B-cell lymphomas,...” NCT02678299 ↗373“Patients receive a preparative lymphodepleting chemotherapy of intravenous cyclophosphamide and fludarabine from day -5 until day -3 (or Bendamustine on day -3 and day -2),...” NCT07166549 ↗ “The patients will be given Bendamustine (90mg/m2 d1,2, every 28 days for total 6 courses) combined with Rituximab (375mg/m2 d0, every 28 days for total 6 courses) followed by...” NCT04842318 ↗ “Clinical and safety outcomes of BeEAM (Bendamustine, Etoposide, Cytarabine, Melphalan) versus CEM (Carboplatin, Etoposide, Melphalan) in lymphoma patients as a conditioning...” PMID 39134959 ↗ Aug 2024 “A Phase 1, Multi-center, Open-label, Uncontrolled, Dose-escalation Trial to Evaluate the Safety of OPB-111077 in Combination With Bendamustine and Rituximab in Patients With...” NCT04049825 ↗ “During the induction therapy phase, patients will receive 90 mg/m2 of bendamustine and 375 mg/m2 zuberitamab from cycles 1 to 3, followed by 150 mg of orelabrutinib and 375...” NCT07008053 ↗ “Subjects will receive a lymphodepletion regimen of bendamustine 70 mg/m2 IV and fludarabine 30 mg/m2 each as a daily infusion for 3 consecutive days prior to the...” NCT06090864 ↗ “A Phase 1b, Multicenter, Open-label Study of Acalabrutinib in Combination With Bendamustine and Rituximab (BR) or Venetoclax and Rituximab (VR) in Subjects With Mantle Cell Lymphoma” NCT02717624 ↗ “The study objectives of this study are to determine the effects, safety, and pharmacokinetics of bendamustine for multiple myeloma to a regimen of bendamustine and prednisolone.” NCT01179490 ↗ “Drug: Bendamustine Schedule: Day 2: Bendamustine 90mg/mq Day 3: Bendamustine 90mg/mq for a maximum of 4 cycles Other Name: Ribomustin” NCT05660993 ↗ “A Phase II Trial of High-dose Bendamustine, Etoposide, Cytarabine, and Melphalan (BeEAM) in the Up-front Treatment of Multiple Myeloma” NCT02416206 ↗ |
| Known as | BEN | “Bendamustine (BEN)” NCT02763319 ↗ |
| Known as | Bendamustine (Treanda; Ribomustin) | “Bendamustine (Treanda; Ribomustin)” NCT01221103 ↗ |
| Known as | Bendamustine - Treanda | “Bendamustine - Treanda” NCT02148913 ↗ |
| Known as | Bendamustine / Brand: Treanda | “Bendamustine / Brand: Treanda” NCT01131247 ↗ |
| Known as | Bendamustine HCL | “The purpose of this study is to determine whether bendamustine HCl for injection is safe and effective in the treatment of Rituximab refractory or relapsed B-cell indolent lymphoma.” NCT01570049 ↗3“Bendamustine HCl is a chemotherapy agent that is effective in treating patients with various diseases, including non-Hodgkin's lymphoma, multiple myeloma, and breast cancer.” NCT00705250 ↗ “bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days” NCT00867503 ↗ “Drug: Bendamustine HCl” NCT00139841 ↗ |
| Known as | Bendamustine Hydrochloride | “The purpose of this study is to assess the antitumor effects and safety of bendamustine hydrochloride (SyB L-0501) in patients with indolent B-cell non-Hodgkin's lymphoma or...” NCT00612183 ↗34“The purpose of this study is to assess the tolerability, pharmacokinetics and antitumor effect of bendamustine hydrochloride (SyB L-0501) in patients with indolent B-cell...” NCT00389051 ↗ “Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing.” NCT01429025 ↗ “A Multicenter, Open-Label, Phase 2 Study of SyB L-0501 (Bendamustine Hydrochloride) for Patients With Multiple Myeloma” NCT01179490 ↗ “Patients receive bendamustine hydrochloride intravenously (IV) over 60-180 minutes on days 1 and 2.” NCT02315157 ↗ “bendamustine hydrochloride IV over 30 minutes on days 1-2” NCT01412879 ↗ “SyB L-0501RI (Bendamustine Hydrochloride for Injection)” NCT03900377 ↗ “Drug: Bendamustine Hydrochloride Injection” NCT01657955 ↗ “bendamustine hydrochloride [bendamustine]” NCT03269669 ↗ “Drug: bendamustine hydrochloride” NCT00984542 ↗ “Drug: Bendamustine hydrochloride” NCT01108341 ↗ |
| Known as | Bendamustine hydrochloride injection | “Bendamustine hydrochloride injection 120 mg/m² or 100 mg/m² intravenously (IV) on Day 1 and Day 2 of 21-day cycle” NCT04569838 ↗ |
| Known as | Bendamustine hydrochloride; Ribomustin | “Bendamustine hydrochloride; Ribomustin” NCT03492775 ↗ |
| Known as | Bendamustine( Leweixin, Chia Tai TIANQING, China) | “Bendamustine( Leweixin®, Chia Tai TIANQING, China)” NCT04762745 ↗ |
| Known as | Levact (Bendamustine) | “Levact (Bendamustine)” NCT02237261 ↗ |
| Known as | Ribomustin | “Bendamustine 90mg/mq for a maximum of 4 cycles Other Name: Ribomustin” NCT05660993 ↗ |
| Known as | Robimustin : Bendamustine | “Robimustin : Bendamustine” NCT01045681 ↗ |
| Known as | SDX-105 | “SUMMARY: This is a multi-center open label study to evaluate the safety and effectiveness of Treanda™ (also known as bendamustine HCl or SDX-105) in patients who have indolent...” NCT00139841 ↗ |
| Known as | SyB L-0501 | “The purpose of this study is to assess the antitumor effects and safety of bendamustine hydrochloride (SyB L-0501) in patients with indolent B-cell non-Hodgkin's lymphoma or...” NCT00612183 ↗7“The purpose of this study is to assess the tolerability, pharmacokinetics and antitumor effect of bendamustine hydrochloride (SyB L-0501) in patients with indolent B-cell...” NCT00389051 ↗ “A Multicenter, Open-Label, Phase 2 Study of SyB L-0501 (Bendamustine Hydrochloride) for Patients With Multiple Myeloma” NCT01179490 ↗ “bendamustine (SyB L-0501: 90 mg/m\^2/day)” NCT01849848 ↗ |
| Known as | SyB L-0501RI | “SyB L-0501RI (Bendamustine Hydrochloride for Injection)” NCT03900377 ↗ |
| Known as | Treanda | “SUMMARY: This is a multi-center open label study to evaluate the safety and effectiveness of Treanda™ (also known as bendamustine HCl or SDX-105) in patients who have indolent...” NCT00139841 ↗ |
| Known as | Trenda | “Ofatumumab (Azerra) + bendamustine (Trenda)” NCT01131247 ↗ |
| Action | Inhibit | “Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.” NCT00939328 ↗ |
| Modality | Small molecule | “Bendamustine is a bifunctional alkylating agent with proven activity in myeloma.” PMID 25911554 ↗ Apr 2015 |
| Route | Intravenous | “30-60 minute intravenous infusion” NCT00069758 ↗ |