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Last update 06 Sep 2025

Dacarbazine

Last update 06 Sep 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

4-(3,3-dimethyl-1-triazeno)imidazole-5-carboxamide, 4-(5)-(3,3-dimethyl-1-triazeno)imidazole-5(4)-carboxamide, 4-(dimethyltriazeno)imidazole-5-carboxamide

+ [18]

Target

DNA

Action

inhibitors

Mechanism

DNA inhibitors(DNA inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [4]

Active Indication

PheochromocytomaMalignant melanoma, metastaticHodgkin's Lymphoma+ [6]

Inactive Indication

High Grade SarcomaLeiomyosarcomaMelanoma recurrent+ [8]

Originator Organization

Southern Research Institute

National Cancer Institute

Active Organization

National Cancer Institute

medac Gesellschaft für klinische Spezialpräparate mbH

Nanjing Pharmaceutical Factory

+ [2]

Inactive Organization

Radiation Therapy Oncology Group

Bayer AG

Bayer HealthCare Pharmaceuticals, Inc.

+ [4]

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (27 May 1975),

Hodgkin's LymphomaMelanoma

Regulation-

Structure/Sequence

Molecular FormulaC6H10N6O

InChIKeyFDKXTQMXEQVLRF-UHFFFAOYSA-N

CAS Registry4342-03-4

182

Clinical Trials associated with Dacarbazine

NCT06835049

/ RecruitingPhase 2IIT

Feasibility of Total Neoadjuvant Treatment With HYPErthermia in Patients With High-risk Extremity and Trunk Soft Tissue Sarcoma (TNT-HYPE). A Multicenter, Single Arm, Open Label, Phase II Trial

Soft tissue sarcomas (STSs) are rare cancers with a 5-year survival rate of 60%, and there is no standard treatment for high-risk extremity and trunk STSs (eSTS). A phase III trial suggests that adding moderate regional hyperthermia (HT) to anthracycline-based chemotherapy, followed by surgery and radiotherapy (RT), can improve 10-year overall survival by 10%. This trial aims to optimize treatment by combining the most effective regimens from chemotherapy, HT, RT, and surgery, and will evaluate the feasibility of this new total neoadjuvant treatment (TNT) approach.

Start Date15 Aug 2025

Sponsor / Collaborator

Swiss Group for Clinical Cancer Research

NCT07002216

/ RecruitingPhase 2IIT

A Phase 2 Trial of Abbreviated Brentuximab Vedotin, Etoposide, Cyclophosphamide, Adriamycin, Dacarbazine, and Dexamethasone (BrECADD) Therapy in Stage 2 B-IV Hodgkin Lymphoma

The purpose of this study is to further assess the efficacy and tolerability of a regimen of Brentuximab Vedotin, Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine, and Dexamethasone (BrECADD) in patients with Stage 2 B-IV Hodgkin Lymphoma (HL) with an exploratory objective to assess the clinical utility of Circulating tumor DNA (ctDNA) as a biomarker for minimal residual disease (MRD) and depth of treatment response.

Start Date15 Jul 2025

Sponsor / Collaborator

University of Miami

[+1]

NCT06984146

/ RecruitingPhase 2IIT

Flat-dose Nivolumab (40 mg) in Combination With Doxorubicin, Vinblastine, and Dacarbazine (AVD) for Newly Diagnosed Advanced Classic Hodgkin Lymphoma

The aim of the current trial is to evaluate the efficacy and safety of flat-dose nivolumab (40 mg) in combination with AVD in the management of patients with newly diagnosed advanced classic Hodgkin Lymphoma

Start Date15 Apr 2025

Sponsor / Collaborator

Russian Ministry of Health

100 Clinical Results associated with Dacarbazine

100 Translational Medicine associated with Dacarbazine

100 Patents (Medical) associated with Dacarbazine

5,000

Literatures (Medical) associated with Dacarbazine

01 Dec 2025·Blood Research

Treatment of older patients with Hodgkin lymphoma

Review

Author: Park, Chung Hyun ; Cho, Hyunsoo ; Kim, Soo-Jeong

Abstract:

Older patients with classic Hodgkin lymphoma (HL) often experience poor outcomes due to age-related comorbidities and treatment-related toxicity. Comprehensive geriatric assessment and supportive care measures, including pre-phase corticosteroids, growth factor prophylaxis, and organ function monitoring, are essential for optimizing treatment tolerance in this vulnerable patient population. Recent phase III trial (S1826) demonstrated that nivolumab plus doxorubicin, vinblastine, and dacarbazine (Nivo + AVD) significantly improves progression-free survival and is better tolerated than brentuximab vedotin (BV) + AVD, particularly in patients over 60 years of age. Given its efficacy and reduced toxicity, Nivo + AVD is likely to become a key treatment option for fit older patients with HL. For frail patients, chemo-free approaches with BV and checkpoint inhibitors remain viable alternatives. Future research should refine fitness-based treatment strategies, integrate novel agents, and enhance supportive care to improve outcomes and minimize treatment-related toxicity in this population.Graphical Abstract

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

WT161, a selective HDAC6 inhibitor, decreases growth, enhances chemosensitivity, promotes apoptosis, and suppresses motility of melanoma cells

Article

Author: Castro-Gamero, Angel Mauricio ; Oliveira, Leilane Sales ; Aissa, Alexandre Ferro ; de Almeida Lima, Graziela Domingues ; Ionta, Marisa ; Fonseca, Rafael ; de Souza, Carlos Vinicius Expedito ; Oliveira-Silva, João Marcos ; Chiminazo, Carolina Berraut

PURPOSE:

Histone deacetylase 6 (HDAC6) plays a critical role in tumorigenesis and tumor progression, contributing to proliferation, chemoresistance, and cell motility by regulating microtubule architecture. Despite its upregulation in melanoma tissues and cell lines, the specific biological roles of HDAC6 in melanoma are not well understood. This study aims to explore the functional effects and underlying mechanisms of WT161, a selective HDAC6 inhibitor, in melanoma cell lines.

METHODS:

Cell proliferation was assessed using both 2D and 3D cell culture systems, including MTT assays, spheroid growth analyses, and colony formation assays. The interaction between WT161 and the chemotherapeutic agents temozolomide (TMZ) or dacarbazine (DTIC) was evaluated using the Chou-Talalay method. Apoptotic cell death was analyzed through flow cytometry, while migration, adhesion, and invasion assays were conducted to evaluate the motility capacities of melanoma cells. Western blot assays quantified α-tubulin acetylation (Lys40), PARP cleavage, and protein levels of β-catenin and E-cadherin.

RESULTS:

WT161 significantly reduced cell growth in both 2D and 3D cultures, decreased clonogenic capacity, and showed synergistic interactions with TMZ and DTIC. The inhibitor also induced apoptotic cell death and enhanced TMZ-induced apoptosis. Additionally, WT161 reduced cell migration and invasion while increasing cell adhesion. These effects were linked to changes in β-catenin and E-cadherin levels, depending on the specific cell type evaluated.

CONCLUSION:

Our study underscores the pivotal role of HDAC6 in melanoma progression, establishing it as a promising therapeutic target. We provide the first comprehensive evidence of WT161's anti-melanoma effects, setting the stage for further research into HDAC6 inhibitors as a potential strategy for melanoma treatment.

01 Oct 2025·CURRENT MEDICINAL CHEMISTRY

Parthenolide Inhibits Tumor Cell Growth and Metastasis in Melanoma A2058 Cells

Article

Author: Bahrami, Afsaneh ; Dorostgou, Zahra ; Mohtashami, Mahnaz ; Zhiani, Rahele ; Hosseiny, Malihesadat

Background::

Skin melanoma is a potentially lethal cancer and ranks as the 17th most common cancer worldwide. Overcoming resistance to advanced-stage melanoma is a significant challenge in its treatment. Parthenolide (PAR) is recognized as a potent anticancer small molecule, yet its potential in treating melanoma is poorly investigated.

Objective::

Our objective was to investigate the apoptotic and anti-metastatic properties of PAR against the A2058 melanoma cells in vitro.

Methods::

This study employed various assays, such as cytotoxicity, apoptosis, cell cycle analysis, reactive oxygen species (ROS) production, mRNA expressions, western blotting, gelatin zymography, and scratch assay. The synergy between PAR and dacarbazine, a chemotherapy drug for treating skin cancer, was also assessed.

Results::

Our study revealed that PAR significantly reduced the viability of A2058 cancer cells, demonstrating greater potency against cancer cells compared to normal L929 cells (IC50: 20 μM vs. 27 μM after 24h). PAR increased ROS production, elevated mRNA expression of pro-apoptotic Bax and NME1 genes, and decreased expression of the MITF gene. PAR induced apoptosis and cell cycle arrest in A2058 cells, as evidenced by the increased proportion of cells in the late apoptotic phase and sub-G1 cell cycle arrest. MMP-2 and MMP-9 mRNA and protein expressions, gelatinase activity, and the migration of A2058 cells were also decreased by PAR, suggesting its potential to suppress cancer cell invasion.

Conclusion::

These results, along with the synergic effect with dacarbazine, indicated that PAR may have the potential to be a therapeutic drug for melanoma by triggering apoptosis and suppressing invasion and migration.

149

News (Medical) associated with Dacarbazine

24 Jun 2025

·pipelinereview.com

Thermosome Reports Encouraging Clinical Data of THE001 in Advanced Soft Tissue Sarcomas

MUNICH, Germany I June 24, 2025 I Thermosome GmbH , a clinical-stage drug development company focused on targeted tumor therapies, today announced new, encouraging data from its ongoing Phase I clinical trial evaluating its lead compound THE001 (DPPG 2 -TSL-DOX) in combination with regional hyperthermia (RHT) for the treatment of soft tissue sarcomas (STS). The Phase I study is assessing the safety, pharmacokinetics (PK), and preliminary efficacy of THE001 + RHT in participants with locally advanced unresectable or metastatic STS, who have exhausted all prior treatment options, including standard doxorubicin (DOX). Despite the early stage of development and a small number of participants, signs of meaningful clinical activity have emerged. Among the heavily pre-treated participants – including patients pre-treated with DOX – the median progression-free survival (PFS) following treatment with THE001 + RHT reached 4.5 months across both dose levels (20 and 40 mg/m²). This exceeds the typical median PFS of 2.7 to 3.5 months observed with first-line DOX therapy in treatment-naïve patients at DOX doses of 75 mg/m 2 , i.e., 2-4x higher than doses of THE001 applied in the Phase I setting. At dose level 2 (40 mg/m²), the mean PFS reached 7.1 months. Two out of three participants in this dose level achieved a partial response (PR) according to Choi criteria and completed the maximum extended treatment phase of 12 cycles (~8.3 months). Notably, one participant whose tumor was initially considered unresectable, could undergo surgical resection at the end of the extended study treatment. This participant showed a tumor shrinkage of -16% in the sum of target lesions, a partial response according to Choi criteria and no vital tumor cells in the resected target lesion. Across dose levels 1 and 2, THE001 + RHT demonstrated a favorable safety profile. There were no dose-limiting toxicities or high-grade treatment-related adverse events that led to treatment discontinuation, underscoring the good tolerability of THE001 in combination with RHT. “These findings not only provide consistent proof of the galenic concept of heat-triggered, largely complete DOX release from THE001, but also demonstrate clinical benefit in a highly challenging patient population,” said Dr. Frank Hermann, Chief Medical Officer of Thermosome. “We are particularly encouraged by the results of one participant who underwent resection after 12 full treatment cycles with THE001 and regional hyperthermia with no vital tumor cells found in the resected target lesion. These results clearly support future exploration in the neoadjuvant setting.” Alexander Eggermont, Professor of Clinical and Translational Immunotherapy, University Medical Center, Utrecht, and a member of Thermosome´s Clinical Advisory Board, commented: “The Phase I data of THE001, a thermosensitive liposomal DOX, and regional hyperthermia in heavily pre-treated DOX-experienced soft tissue sarcoma patients, particularly from dose level 2, are very encouraging. These results demonstrate the clinical potential of this highly innovative approach and provide the necessary foundation for transitioning into Phase II proof-of-concept development. I am excited to support this important work and look forward to advancing this promising therapy, which has the potential to significantly improve outcomes for patients with soft tissue sarcoma, particularly in the neoadjuvant setting.” “It is exciting to see the promising results of THE001 combined with regional hyperthermia, demonstrating strong potential to address the high unmet need for better treatments for soft tissue sarcoma,” added Prof. Shreyaskumar Patel, the Robert R. Herring Distinguished Professor of Medicine and Medical Director of the Sarcoma Center at The University of Texas MD Anderson Cancer Center, Houston Texas, and a member of Thermosome’s Clinical Advisory Board. ”Expansion into Phase II, also including the U.S., would offer a much-needed validation of this new therapeutic strategy for patients with STS. I look forward to supporting the advancement of this innovative treatment option to improve outcomes for patients here in the U.S. and globally on the back of the orphan drug designation granted by the FDA.” Considering supportive feedback from the German Federal Institute for Drugs and Medical Devices (BfArM) on the development of THE001 + RHT in the neoadjuvant setting, the available data from last-line participants are intended to support further development in the neoadjuvant setting. About Thermosome Thermosome is a clinical-stage drug development company focused on targeted tumor therapy combined with immune stimulation for improved cancer therapy. At its core is a novel, proprietary tumor targeting approach that allows for significantly increased local drug concentration and improved tumor penetration to achieve improved clinical treatment efficacy. The first clinical indication for its lead drug candidate THE001 is soft tissue sarcoma, where the Company aims to improve the current standard of care (free doxorubicin). Thermosome’s approach enables targeted tumor treatment independent of specific molecular targets and covers patient populations across all chemo-sensitive tumor subtypes. More information: www.thermosome.com About THE001 Thermosome’s clinical-stage lead drug candidate THE001 is a thermosensitive liposomal formulation of the chemotherapeutic drug doxorubicin (DPPG 2 -TSL-DOX). It has a different mode of action than conventional liposomes. Thermosome’s technology enables intravascular drug release initiated by a mild heat trigger using clinically established hyperthermia devices. This results in up to 15-fold higher local drug concentrations in the tumor and aims to improve clinical treatment efficacy by creating a local boost at the desired site of action. These high local concentrations, which also reach less well perfused areas, are intended to overcome drug resistance. This effect cannot be achieved by administration of conventional doxorubicin due to systemic toxicity. Thermosome intends to further enhance treatment efficacy through an additive immune response induced by regional hyperthermia. THE001 has potential for further development in other anthracycline-sensitive solid tumors, such as breast, bladder, and ovarian cancer. THE001 has been granted Orphan Drug Designation for STS in Europe and the United States. About the Phase I Study The Phase I, open-label, interventional dose-escalation trial enrolling patients with (including DOX-) pre-treated locally advanced unresectable or metastatic STS ( NCT05858710 ) is being conducted at two German clinical sites testing THE001 at various different dose levels in initially up to 6 cycles every 3 weeks with option to extend to up to 12 cycles in participants with at least disease control. Both completed dose level (20 mg/m² and 40 mg/m²) were well tolerated and declared safe by the independent data safety monitoring board (DSMB). Primary endpoints of the study are the safety and tolerability of THE001 and the determination of the maximum tolerated dose. A secondary objective is the evaluation of anti-tumor activity. Initial clinical data were presented at the CTOS 2024 Annual Meeting ( link ). About Soft Tissue Sarcomas (STS) STS is an atypical tumor with a patient population that includes many young patients. Locally advanced STS (LA-STS) are large invasive tumors that are difficult or impossible to resect. Neoadjuvant therapy is used to shrink these tumors preoperatively to allow tumor surgery with curative intent. Free doxorubicin in combination with ifosfamide or dacarbazine has been the gold standard for neoadjuvant therapy of all chemo-sensitive LA-STS for several decades. Guidelines also recommend combining DOX-based therapy with regional hyperthermia. However, with response rates of less than 30%, there is a significant unmet need for improved treatment options. Soft tissue sarcomas occur in more than 50 different subtypes that do not share a common driver mutation, making biologic targeting more difficult than physically controlled targeting with the most active agent. SOURCE: Thermosome

Phase 1Clinical ResultOrphan DrugImmunotherapyASCO

04 Jun 2025

·pipelinereview.com

European Commission Approves ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Newly Diagnosed Stage IIb/III/IV Hodgkin Lymphoma in Combination with ECADD

– Approval Based on Positive Results from the Phase 3 HD21 Trial for Stage IIb with Risk Factors/III/IV Hodgkin Lymphoma – ADCETRIS-based Combination Demonstrated Superior Safety Profile and Efficacy Compared to eBEACOPP, a Standard of Care Regimen in Europe – Second Approval in Frontline Hodgkin Lymphoma Broadens ADCETRIS’ Therapeutic Reach, Adding to Six Previously Approved, Distinct Indications for ADCETRIS in the European Union OSAKA, Japan & CAMBRIDGE, MA, USA I June 03, 2025 I Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Commission (EC) approved ADCETRIS ® (brentuximab vedotin) in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) – a chemotherapy regimen – in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on April 25, 2025. The approval for this ADCETRIS-based combination regimen, known as BrECADD, in frontline Hodgkin lymphoma is based on the results of the randomized Phase 3 HD21 trial. The study met its co-primary safety and efficacy endpoints, with BrECADD demonstrating significantly superior safety as assessed by treatment-related morbidity (TRMB) and non-inferior progression-free survival (PFS) in comparison to escalated doses of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone (eBEACOPP), a standard of care treatment in Europe 1 . “Today’s approval represents a significant advancement for patients with Hodgkin lymphoma in the European Union,” said Teresa Bitetti, president of the Global Oncology Business Unit at Takeda. “This approval reinforces the role of ADCETRIS as a backbone in the treatment of specific lymphomas, offering healthcare professionals greater flexibility to tailor treatment plans according to individual patient needs. We’re proud to contribute another impactful option for those diagnosed with this challenging disease.” ADCETRIS is an antibody-drug conjugate (ADC) directed at CD30, a defining marker of Hodgkin lymphoma, and has been previously approved as a therapy for adult patients in the European Union (EU) in six distinct indications. This decision marks the second approval for an ADCETRIS-based combination regimen for frontline Hodgkin lymphoma, broadening the spectrum of available treatments for patients who historically have had limited options. “With BrECADD, patients now have a treatment option that not only offers greater curative potential 2* but also significantly reduces treatment-related morbidity compared to eBEACOPP,” said Peter Borchmann, MD, PhD, University Hospital of Cologne, Germany, and trial chairman of the HD21 study. “This new ADCETRIS-based combination therapy may offer a new standard of care for frontline treatment of adults with advanced stage Hodgkin lymphoma, contributing to improved long-term outcomes for patients.” About the HD21 Trial The HD21 study is a Phase 3, multi-country, prospective, open-label, randomized, multicenter trial conducted by the German Hodgkin Study Group (GHSG) with a PET-response adapted designed to assess the feasibility, efficacy, safety and tolerability of BrECADD, a novel, rationally designed, CD30-intensified frontline regimen for patients with advanced Hodgkin lymphoma. Enrolled patients with newly diagnosed, Stage IIb with large mediastinal mass and/or extranodal lesions, Stage III or IV Hodgkin lymphoma were randomized to receive two cycles of either escalated BEACOPP or BrECADD, respectively, followed by interim PET staging. A decision is then made if patients received a further two or four cycles of escalated BEACOPP or BrECADD. The HD21 trial aims to evaluate a new treatment regimen to minimize side effects, while maintaining similar responses to treatment. The study has co-primary endpoints: safety is assessed by treatment-related morbidity (TRMB) (superiority), a novel endpoint focused on clinically relevant, acute toxicities of primary chemotherapy, and efficacy is assessed by PFS (non-inferiority). Secondary endpoints are tumor response (complete response [CR] rate), overall survival (OS), infertility rate at one year, second malignancies, frequency of adverse events, therapy adherence and quality of life. About ADCETRIS® (brentuximab vedotin) ADCETRIS is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Pfizer’s proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-positive tumor cells. ADCETRIS injection for intravenous infusion has received FDA approval for eight indications: Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-autologous stem cell transplantation (ASCT) consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression in 2017, adults with pcALCL or CD30-expressing MF who have had prior systemic therapy in 2018, for previously untreated Stage IV Hodgkin lymphoma in combination with doxorubicin, vinblastine, and dacarbazine in 2019, and for previously untreated adult patients with sALCL, peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma (AITL), whose tumors express CD30, in combination with cyclophosphamide, doxorubicin, prednisone in 2019. ADCETRIS received conditional marketing authorization from the European Commission in October 2012, and the specific obligations of the conditional marketing authorization were fulfilled in May 2022. The approved indications in the European Union are: (1) for the treatment of adult patients with previously untreated CD30-positive Stage III or IV Hodgkin lymphoma in combination with doxorubicin, vinblastine and dacarbazine (AVD), (2) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, (3) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (4) for the treatment of adult patients with relapsed or refractory sALCL, (5) for the treatment of adult patients with previously untreated sALCL in combination with CHP, (6) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy and (7) for the treatment of adult patients with previously untreated CD30+ Stage IIB with risk factors, Stage III or Stage IV HL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD). ADCETRIS has received marketing authorization by regulatory authorities in 80 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See Important Safety Information below. ADCETRIS is being evaluated broadly in more than 70 clinical trials, including a Phase 3 study in first-line Hodgkin lymphoma (ECHELON-1) and another Phase 3 study in first-line CD30-positive peripheral T-cell lymphomas (ECHELON-2), as well as trials in many additional types of CD30-positive malignancies. Pfizer and Takeda fund joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs. Please see the full Prescribing Information, including BOXED WARNING, for ADCETRIS here . About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com . Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. Footnotes: *While late relapse is rare, PFS status after 5 years does not guarantee cure. Patients should be monitored and encouraged to report any return of symptoms as appropriate. References: SOURCE: Takeda Pharmaceutical

Phase 3Drug ApprovalClinical ResultImmunotherapyADC

04 Jun 2025

·pmlive.com

Takeda receives EC approval for Adcetris combination in Hodgkin lymphoma

Takeda has received approval from the European Commission (EC) for its Pfizer-partnered blood cancer drug Adcetris (brentuximab vedotin). The drug has been approved in combination with the chemotherapy regimen etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) to treat newly diagnosed stage 2b Hodgkin lymphoma (HL) in adults with risk factors/3/4. The authorisation follows a recent recommendation from the European Medicines Agency’s human medicines committee and was based on positive results from the phase 3 HD21 study. The trial achieved its co-primary endpoints, with the Adcetris regimen demonstrating significantly improved safety, as assessed by treatment-related morbidity, and non-inferior progression-free survival compared to escalated doses of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone (eBEACOPP), a standard of care in Europe. HD21 trial chairman, Peter Borchmann, University Hospital of Cologne, said: “With [the Adcetris regimen], patients now have a treatment option that not only offers greater curative potential but also significantly reduces treatment-related morbidity compared to eBEACOPP. “This new Adcetris-based combination therapy may offer a new standard of care for front-line treatment of adults with advanced stage HL, contributing to improved long-term outcomes for patients.” HL originates from abnormal lymphocytes and is distinguished from other types of lymphoma by the presence of Reed-Sternberg cells, which typically carry the CD30 protein on their surface. Approximately 82,469 new cases of the disease were reported globally in 2022. Adcetris, an antibody-drug conjugate (ADC) directed at CD30, is already approved in the EU for six other adult indications and the EC’s latest decision marks the second approval for an Adcetris-based combination regimen for front-line HL. Teresa Bitetti, president of Takeda’s global oncology business unit, said the approval “represents a significant advancement for patients with HL in the EU”. “This approval reinforces the role of Adcetris as a backbone in the treatment of specific lymphomas, offering healthcare professionals greater flexibility to tailor treatment plans according to individual patient needs. We’re proud to contribute another impactful option for those diagnosed with this challenging disease,” Bitetti added. Takeda is responsible for Adcetris’ commercialisation everywhere except the US and Canada, where Pfizer holds commercialisation rights.

Drug ApprovalClinical ResultPhase 3ADCImmunotherapy

100 Deals associated with Dacarbazine

External Link

KEGG	Wiki	ATC	Drug Bank
D00288	Dacarbazine	L01AX04	DB00851

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Pheochromocytoma	Japan	Sandoz AG	25 Mar 2013
Malignant melanoma, metastatic	Brazil	Libbs Farmacêutica Ltda.	27 Nov 2006
Metastatic melanoma	Austria	medac Gesellschaft für klinische Spezialpräparate mbH	08 Oct 1997
Metastatic melanoma	Belgium	medac Gesellschaft für klinische Spezialpräparate mbH	08 Oct 1997
Metastatic melanoma	Denmark	medac Gesellschaft für klinische Spezialpräparate mbH	08 Oct 1997
Metastatic melanoma	Germany	medac Gesellschaft für klinische Spezialpräparate mbH	08 Oct 1997
Metastatic melanoma	Ireland	medac Gesellschaft für klinische Spezialpräparate mbH	08 Oct 1997
Metastatic melanoma	Italy	medac Gesellschaft für klinische Spezialpräparate mbH	08 Oct 1997
Metastatic melanoma	Netherlands	medac Gesellschaft für klinische Spezialpräparate mbH	08 Oct 1997
Metastatic melanoma	Portugal	medac Gesellschaft für klinische Spezialpräparate mbH	08 Oct 1997
Metastatic melanoma	Sweden	medac Gesellschaft für klinische Spezialpräparate mbH	08 Oct 1997
Metastatic melanoma	United Kingdom	medac Gesellschaft für klinische Spezialpräparate mbH	08 Oct 1997
Lymphoma	China	Nanjing Pharmaceutical Factory	01 Jan 1985
Soft Tissue Neoplasms	China	Nanjing Pharmaceutical Factory	01 Jan 1985
Hodgkin's Lymphoma	United States	Bayer HealthCare Pharmaceuticals, Inc.	27 May 1975
Melanoma	United States	Bayer HealthCare Pharmaceuticals, Inc.	27 May 1975

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Melanoma recurrent	Phase 3	-	National Cancer Institute	01 Apr 2002
Melanoma, Cutaneous Malignant	Phase 3	United States	-	01 Aug 2000
Melanoma, Cutaneous Malignant	Phase 3	Australia	-	01 Aug 2000
Non-Hodgkin Lymphoma	Phase 2	United States	-	13 Oct 2017
Relapsing classical Hodgkin lymphoma	Phase 2	United States	-	13 Oct 2017
Uveal Melanoma	Phase 2	United States	National Cancer Institute	31 Jul 2013
Uveal Melanoma	Phase 2	Canada	National Cancer Institute	31 Jul 2013
Acquired Immunodeficiency Syndrome	Phase 2	United States	National Cancer Institute	08 Mar 2013
Acquired Immunodeficiency Syndrome	Phase 2	France	National Cancer Institute	08 Mar 2013
Classical Hodgkin's Lymphoma	Phase 2	United States	National Cancer Institute	08 Mar 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03517137 (COBRA \| EORTC-1537-COBRA, CTgov)	Phase 2	Hodgkin's Lymphoma \| Relapsing classical Hodgkin lymphoma	150	Radiation Therapy+Dacarbazine+Etoposide+Cyclophosphamide+Adriamycin+Vinblastine+Brentuximab Vedotin	nzulvwbrop(ecawtgrcfz) = pswzeukmmv jhjntmiubb (ntivxbqzqy, jwgplvsveu - yrrqctlzjt) View more	-	11 Aug 2025
["HD21"] (Pubmed \| J Clin Oncol)	Phase 2	Classical Hodgkin's Lymphoma First line	83	Brentuximab vedotin + Etoposide + Cyclophosphamide + Doxorubicin + Dacarbazine + Dexamethasone (BrECADD) (PET2-negative)	psjsoiugab(eyfheqikts) = whpidjancj znvvyhqcyb (paotlqfngv, 84 - 98) View more	Positive	17 Jul 2025
NCT03277924 (Phase Ib Study, Pubmed \| J Clin Oncol)	Phase 1	Leiomyosarcoma HMGB1	24	Doxorubicin 75 mg/m2	uabkmkjqpd(lglamubtbl) = 16.7% hkbytdqdys (pibpunhhsz ) View more	Positive	20 Jan 2025
NCT03331341 (4429, CTgov)	Phase 1/2	Classical Hodgkin's Lymphoma	50	Laboratory Biomarker Analysis+Dacarbazine+Doxorubicin Hydrochloride+Pembrolizumab+Vinblastine	uoriiouffb = odndqdaqou qfghethczn (femudnksok, oszeeboiyz - frhbkaigdu) View more	-	09 Jan 2025
NCT03907488 (S1826, Pubmed) Manual	Phase 3	Classical Hodgkin's Lymphoma	994	Brentuximab vedotin with doxorubicin, vinblastine, and dacarbazine (BV+AVD)	subgeurwot(ryzrbxkwms) = ypzxncemax hlrivonmqq (jimcjuzctd, 79 - 86)	Positive	17 Oct 2024
				Nivolumab with doxorubicin, vinblastine, and dacarbazine (N+AVD)	subgeurwot(rrjweuivse) = tqseyosxco atqxeqtemx (ffnyvsabxu ) View more
NCT01712490 (ECHELON-1, ASCO2024) Manual	Phase 3	Classical Hodgkin's Lymphoma First line	-	A+AVDbrentuximab vedotindoxorubicinvinblastinedacarbazine	ntphuwllie(mndmrxzqje) = bpldbjzxup hvzwpjioyi (rrmsvflykj, 91.1 - 95.2) View more	Positive	24 May 2024
				ABVDdoxorubicinbleomycinvinblastinedacarbazine	ntphuwllie(mndmrxzqje) = zhxousnstu hvzwpjioyi (rrmsvflykj, 85.8 - 91.1) View more
ASCO2024	Not Applicable	Locally Advanced Melanoma pembrolizumab	71	Dacarbazine alone	vtzmhkutod(oqmgyrehvg) = qgwkyitrxd gltlylhxso (chavmzbgbh ) View more	Positive	24 May 2024
				Pembrolizumab + Dacarbazine	vtzmhkutod(oqmgyrehvg) = zikussyhim gltlylhxso (chavmzbgbh ) View more
NCT03517137 (EORTC-1537-COBRA, EHA2024) Manual	Phase 2	Hodgkin's Lymphoma First line	145	A-AVD (Brentuximab vedotin + doxorubicin +vinblastine + dacarbazine)dacarbazine) or BrECADD ( Brentuximab vedotine + etoposide + cyclophosphamide + doxorubicin + dacarbazine + dexamethasone)	tbmhyyqapu(nrotcyiveu) = pdxqfwvkkj ptzccddcnq (kjslxakpuz, 85.7 - 92.4) View more	Positive	14 May 2024
				Brentuximab vedotBrentuximab vedotinnblastine, dacarvinblastineVD)dacarbazine	tbmhyyqapu(nrotcyiveu) = enlzjlnjkv ptzccddcnq (kjslxakpuz )
NCT03407144 (KEYNOTE-667, EHA2024) Manual	Phase 2	Classical Hodgkin's Lymphoma	9	Pembrolizumab +dacarbazine	fkdcnfzdip(bwiiyuccqt) = xsykxiauiw yheaitipfc (ijofoymcop, 66 - 100)	Positive	14 May 2024
NCT01716806 (Pubmed) Manual	Phase 2	Hodgkin's Lymphoma First line	43	Brentuximab vedotin + dacarbazine	ifwtidlevw(bqzqirjfcf) = pyuysgzihb vifkxisrtl (gbbolgygia ) View more	Positive	29 Feb 2024
				Brentuximab vedotin + nivolumab	ifwtidlevw(bqzqirjfcf) = giacaswvwm vifkxisrtl (gbbolgygia ) View more

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