CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Antibody-dependent cellular phagocytosis (ADCP) effects

Therapeutic Areas

NeoplasmsImmune System DiseasesEndocrinology and Metabolic Disease+ [5]

Active Indication

Immunoglobulin Light-Chain AmyloidosisMultiple MyelomaSmoldering Multiple Myeloma+ [19]

Inactive Indication

Adult Lymphoblastic LymphomaExtranodal NK-T-Cell LymphomaFollicular Lymphoma+ [10]

Originator Organization

Janssen Global Services LLC

Active Organization

Xian-Janssen Pharmaceutical Ltd.Janssen R&D Ireland Share Participation Scheme

Janssen Biotech, Inc.

+ [17]

Inactive Organization-

License Organization

Genmab A/S

Janssen Biotech, Inc.

Drug Highest PhaseApproved

First Approval Date

United States (16 Nov 2015),

Multiple Myeloma

RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (United Kingdom), Priority Review (Japan)

Structure/Sequence

Sequence Code 9075449L

Source: *****

Sequence Code 9946743H

Source: *****

324

Clinical Trials associated with Daratumumab

NCT06570915

/ Not yet recruitingPhase 2IIT

A Prospective, Single-arm, Multicenter, Open-label , Phase 2 Study to Evaluate Efficacy and Safety of the Daratumumab in T Cell Acute Lymphoblastic Leukemia With Minimal Residual-Positive After Standard Chemotherapy

T-ALL accounts for about 15%-25% of Ph-negative ALL, and its clinical prognosis is worse than B-ALL. The successful application of immunotherapy has brought revolutionary progress to the treatment of ALL. But progress in the treatment of T-ALL has been relatively slow. Minimal residual disease (MRD) is a strong prognostic indicator for ALL patients. MRD-positive after induction therapy predicts a high risk of relapse. The National Comprehensive Cancer Network (NCCN) considers MRD-positive ALL patients to be at high risk. Research in the B-ALL field has demonstrated that immunotherapy has the potential to further clear MRD, which in turn translates into survival benefits. Daratumumab is a humanized, anti-CD38 IgG1 monoclonal antibody that binds to CD38 expressed by tumor cells. Apoptosis of tumor cells is induced through a variety of immune-related mechanisms such as complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cytophagocytosis (ADCP), and FCγ receptors, which are currently mainly used in the treatment of multiple myeloma. CD38 is highly and stably expressed on the surface of T-ALL cells, and its expression was less influenced by the previous treatment. Preliminary data from the clinical study of daratumumab combined with BFM bone frame prescription for the treatment of recurrent refractory T ALL(NCT03384654) showed that the effectiveness rate (ORR) was 83.3% in children and 60% in young adults. Compared with the previous historical data, the safety and tolerability were significantly improved. For T-ALL patients who relapse after allogeneic transplantation and achieve CR with intense chemotherapy but continue to have MRD-positive flow rate, daratumumab monotherapy can further clear MRD and achieve the purpose of sustaining CR. These studies all demonstrate the potential role of daratumumab in the treatment of T-ALL. Based on the current difficulties in the treatment of T-ALL and existing research data, we plan to conduct a prospective, single-arm, open-label phase II clinical study to explore the efficacy and safety of daratumumab for flow minimal residual disease positive T-ALL after standard chemotherapy.

Start Date01 Dec 2025

Sponsor / Collaborator

Hematology Hospital of Chinese Academy of Medical Sciences

NCT06932562

/ Not yet recruitingPhase 3IIT

A Randomized, Open-Label, Controlled Phase 3 Study of Comparing Daratumumab, Lenalidomide and Dexamethasone Induction Followed by Linvoseltamab Versus Continued Daratumumab, Lenalidomide, and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma Patients

This study is researching an experimental drug called linvoseltamab. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (transplant-ineligible).
The main purpose of this study is to compare the effect and safety of linvoseltamab with the effect and safety of the standard treatment.

Start Date01 Sep 2025

Sponsor / Collaborator

European Myeloma Network

[+1]

NCT06948084

/ Not yet recruitingPhase 2IIT

A Randomized Phase II Trial for High-Risk Multiple Myeloma That is Refractory or in First Relapse With Daratumumab, Teclistamab (DT) Versus Daratumumab, Pomalidomide, Dexamethasone (DPd) or Daratumumab, Carfilzomib, Dexamethasone (DKd)

This phase II trial compares the effect of the combination of daratumumab-hyaluronidase (daratumumab) and teclistamab to the usual treatment of daratumumab, pomalidomide, dexamethasone or daratumumab, carfilzomib and dexamethasone in treating patients with multiple myeloma that has not responded to previous treatment (refractory) or that has come back after a period of improvement (relapsed). Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Teclistamab is a bispecific antibody that can bind to two different antigens at the same time. Teclistamab binds to B-cell maturation antigen, a protein found on some B-cells and myeloma cells, and CD3 on T-cells (a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Pomalidomide is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Carfilzomib, a type of proteasome inhibitor, blocks the action of enzymes called proteasomes, which may help keep cancer cells from growing and may kill them. Giving daratumumab and teclistamab may be more effective than the usual treatment of daratumumab, pomalidomide, dexamethasone or daratumumab, carfilzomib and dexamethasone in reducing myeloma cells to undetectable levels in patients with relapsed or refractory multiple myeloma.

Start Date18 Jul 2025

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Daratumumab

100 Translational Medicine associated with Daratumumab

100 Patents (Medical) associated with Daratumumab

2,037

Literatures (Medical) associated with Daratumumab

31 Dec 2025·ANNALS OF MEDICINE

Serum free light chain level-based and non-fixed cycle daratumumab treatment strategy for patients with light chain amyloidosis

Article

Author: Huang, Xianghua ; Guo, Jinzhou ; Chen, Wencui ; Li, Zhen ; Zhao, Liang ; Ren, Guisheng

BACKGROUND:

In recent years, daratumumab (DARA) has gained widespread use in the treatment of systemic light chain (AL) amyloidosis. In this study, we assessed the efficacy and safety of a DARA treatment strategy based on serum free light chain (sFLC) levels and non-fixed cycles.

METHODS:

The study included 123 patients with Al amyloidosis who received DARA at our center between July 2020 and September 2023. All patients received the standard DARA treatment (16 mg/kg weekly for four weeks) during the first course. Subsequent treatments were adjusted based on sFLC levels and the physician's judgment.

RESULTS:

The results demonstrated an impressive overall hematologic response rate (ORR) of 94.3%, with a hematologic very good partial response (VGPR) and complete response (CR) rate of 84.5%. Median time to best hematologic response was 1 months. Cardiac and renal response rates were 39.3% and 60.3%, respectively. Thirty patients experienced grade 1/2 infusion-related reactions after the first infusion. The rate of grade 3/4 adverse events was 21%. The most common adverse events of grade 3 or 4 were pulmonary infection (6.5%), neutropenia and lymphocytopenia (5.7%), elevated transaminases (1.6%), acute kidney injury (1.6%). After a median follow-up of 13 months (range 1-38), The 1-year OS and PFS estimates were 96.5% and 84.4%, respectively.

CONCLUSION:

These findings indicate that the sFLC levels based and non-fixed cycle DARA strategy is an efficacious and safe treatment strategy in both newly diagnosed and relapsed/refractory AL amyloidosis.

31 Dec 2025·ANNALS OF MEDICINE

Clinical outcome of ≥2% circulating tumor cells in newly diagnosed multiple myeloma: insights from a multicenter study

Article

Author: Liang, Dong ; Wang, Hua ; Xia, Zhongjun ; Feng, Yuan ; Yan, Yurong ; Jin, Fengyan ; Chen, Xiaoqin ; Zeng, Min ; Nie, Xiaomiao ; Bu, Yuying ; Bai, Shenrui ; Liang, Yang ; Wang, Qiaoli ; Xu, Weiling ; Feng, Demei

PURPOSE:

Previous studies have shown that ≥2% circulating tumor cells (CTCs) in multiple myeloma are associated with a prognosis similar to primary plasma cell leukemia. This study aims to examine this ultra-high-risk patient subset and evaluate their clinical outcomes in a real-world clinical setting.

METHODS:

We included 1,056 newly diagnosed multiple myeloma patients treated with novel agents. CTCs levels were determined via morphological assessment on peripheral blood smears, using a 2% cutoff to stratify patients into <2% and ≥2% CTCs groups. We then evaluated clinical outcomes across these groups.

RESULTS:

Patients with ≥2% CTCs constitute an ultra-high-risk subgroup, with outcomes resembling those of primary plasma cell leukemia. Survival outcomes improved for patients receiving daratumumab-based quadruplet therapy. Single autologous stem cell transplantation (ASCT) partially improved outcomes for patients with ≥2% CTCs. Achieving complete remission (CR) after induction treatment did not confer a better prognosis for this population. Furthermore, one high-risk cytogenetic abnormality (HRA) worsened outcomes in the <2% CTC group, while ≥2 HRA were associated with poorer outcomes in the ≥2% CTC group. Concurrent 1q21+ and other HRA further conferred a worse prognosis. In de novo extramedullary extraosseous (EME) multiple myeloma, defined as patients presenting with soft tissue or visceral plasmacytomas not connected to bone at initial diagnosis, ≥2% CTCs remained a strong predictor of poor prognosis.

CONCLUSION:

Our study suggests that patients with ≥2% CTCs represent a distinct ultra-high-risk subgroup in multiple myeloma and warrant separate consideration. VRD, IRD, DVRD, and DRD were reliable choices as frontline therapies for patients with <2% CTCs. Daratumumab-based quadruplet therapy may be a promising option for patients with ≥2% CTCs. Further research should continue to explore this specific aspect in greater depth.

31 Dec 2025·DRUG DELIVERY

Evaluating nurse preferences for a novel on-body delivery system vs. manual syringes for large-volume subcutaneous drug administration: a survey study

Article

Author: Gorski, Lisa A. ; Curry, Nicole ; Sterlin, Valentina ; Miles, Ashley ; Desai, Mehul ; Faiman, Beth

While nurses report challenges with the manual administration of large-volume subcutaneous drugs, these challenges and potential solutions are not captured in the literature. In this cross-sectional study, 45 nurses with experience administering large-volume subcutaneous biologics completed an 18-item survey about preferences for syringes vs. on-body delivery systems. 100% responded that an on-body delivery system seemed easy to learn and use and preferable to syringes. In a drug delivery scenario including comprehensive administration details and assuming equivalent safety and efficacy, 97.78% preferred the on-body delivery system to a daratumumab/hyaluronidase syringe. In the total sample, this preference was primarily attributed to (1) reduced nurse effort due to hands-free delivery, (2) decreased patient pain due to a thinner needle, (3) elimination of needlestick injuries due to a hidden needle, and (4) increased clinic efficiency due to hands-free delivery. 95.56% felt that the on-body delivery system would improve clinic throughput better than syringes. Nurses reported that an on-body delivery system would be easy to learn and use and would improve clinic efficiency and safety. They underscored the importance of decreasing nurse physical burden, needlestick injuries, and patient needle phobia. Contrary to the assumption that speed is paramount, nurses prioritized reducing effort, enhancing administration safety, and improving patient comfort over injection speed.

546

News (Medical) associated with Daratumumab

29 May 2025

·www.prnewswire.com

John Theurer Cancer Center Presents Innovative Cancer Research at Major Annual Cancer Meeting, Offering New Hope for Patients

Presentations and publications address novel therapeutics, molecular biology studies, and global trends for blood cancers and solid tumors HACKENSACK, N.J., May 29, 2025 /PRNewswire/ -- Investigators from Hackensack Meridian John Theurer Cancer Center (JTCC)—part of the National Cancer Institute-designated Lombardi Comprehensive Cancer Center at Georgetown University—and Hackensack University Medical Center are reporting research findings from 32 studies at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The meeting is the premier event for cancer professionals and takes place in Chicago from May 30 to June 3. "The future of cancer treatment begins with the pioneering exploration being carried out today," notes Andre Goy, MD, chair, vice president, physician-in-chief of oncology, at Hackensack Meridian John Theurer Cancer Center. "We are fortunate to be in a time where many cancers will respond to standard treatments. But for those cancers that don't, it's critical that patients have access to a world-class research program that will yield innovative therapies. At John Theurer Cancer Center, our globally recognized investigators continue to drive the latest oncology advances in cellular therapy, immunotherapy and other areas, enabling improved outcomes for patients across the Hackensack Meridian Health network and beyond." Several studies address novel drug combinations for multiple myeloma, as well as racial disparities in treatment outcomes and the expression of key biomarkers. Investigators are also presenting data on emerging immunotherapies for leukemia and lymphoma, molecular markers predicting disease relapse, and innovative treatment regimens such as all-oral therapies for acute myeloid leukemia. Solid tumor studies focus on disparities in gastric cancer, machine learning applications for breast cancer metastasis, and promising antibody-drug conjugates for lung cancer. Investigations related to melanoma and skin cancer examine circulating tumor DNA as a marker for disease progression, comparative survival analyses based on biomarkers, and the identification of targetable mutations across different skin cancer types. These findings underscore the breadth of ongoing efforts at John Theurer Cancer Center—New Jersey's largest cancer center—to refine therapeutic strategies, enhance precision oncology, and improve patient outcomes. Multiple Myeloma Research Carfilzomib, iberdomide, and dexamethasone in patients with transplant-eligible newly diagnosed multiple myeloma: Updated results from phase 1/2 study Updated results from phase 2b study of selinexor in combination with carfilzomib, daratumumab, or pomalidomide in patients with multiple myeloma relapsing on current therapy Real-world outcomes of patients with multiple myeloma treated with T-cell engagers compared to those treated on clinical trials Impact of racial disparities on efficacy and safety outcomes for patients with relapsing/refractory multiple myeloma receiving T-cell engagers Heterogeneity in the expression of GPRC5D between patients with multiple myeloma Evaluation of immune checkpoint inhibitors and concurrent radiation therapy for the treatment of extramedullary multiple myeloma Global burden of multiple myeloma: Analysis from 1980 to 2021 Efficacy and safety of less frequent dosing with elranatamab in patients with relapsed or refractory multiple myeloma: A US subgroup analysis from MagnetisMM-3 Leukemia and Lymphoma Peripheral blood cell-free DNA testing as a predictor for relapse post-allogeneic stem cell transplant for acute myeloid leukemia An all-oral regimen of decitabine-cedazuridine plus venetoclax in patients with newly diagnosed acute myeloid leukemia ineligible for intensive induction chemotherapy: Results from a phase 2 cohort of 101 pts Employing novel pan-cancer targets for immunotherapy in leukemias and solid tumors MRD negativity after end of induction in the phase 3 PhALLCON trial: A post hoc analysis Results from the completed dose-finding part of phase 2 study of the innate cell engager acimtamig (AFM13) in combination with AlloNK (AB-101) in relapsed or refractory classical Hodgkin lymphoma (LuminICE-203) Novel analysis of 3-y results from the pivotal EPCORE NHL-1 study: Outcomes in patients with relapsed/refractory large B-cell lymphoma and complete response at 2 years with epcoritamab monotherapy TITANium: An open-label, global multicenter phase 1/2 study of AZD5492, a first-in-class subcutaneous CD8-guided tri-specific T-cell engager, in patients with relapsed or refractory B-cell malignancies Solid Tumor Research Limited changes in the central nervous system immune microenvironment in patients with breast cancer metastasis and capturing these changes using machine learning Relationship between FOLR1 expression and pan-cancer subgroup of tumors with specific transcriptomic profile Disparities and trends in gastric cancer: Incidence, mortality, and stage-specific trends Prevalence of the HPV, EBV, and TTV viral RNA in the plasma of patients with solid and hematologic neoplasms and the detection of a specific immune signature Global trends in soft tissue and extraosseous sarcomas (1980–2021): Regional and economic disparities ZL-1310, a DLL3 antibody-drug conjugate, in patients with extensive stage small cell lung cancer: Phase 1 trial update Ongoing phase 1/2 trial of the hematopoietic progenitor kinase 1 (HPK1) inhibitor NDI-101150 as monotherapy or in combination with pembrolizumab: Clinical safety and efficacy update in clear cell renal cell carcinoma Ipilimumab and nivolumab in patients with metastatic clear cell renal cell carcinoma treated on the phase 3 PDIGREE (Alliance A031704) trial: Results from Step 1 analysis Initial safety and efficacy results from a first-in-human, phase 1/2 study of SAR445877, an anti-PD-1/IL-15 fusion protein, for patients with advanced solid tumors An open-label, phase I trial of the SIRPα monoclonal antibody, BI 770371, alone and in combination with the PD-1 inhibitor ezabenlimab in patients with advanced solid tumors A phase 1 dose escalation and dose expansion study for LNCB74, a B7-H4 targeted antibody drug conjugate, as monotherapy in participants with advanced solid tumors A phase 1, open-label, multi-center study of the safety, tolerability, and efficacy of IPH4502 as a single agent in advanced solid tumors A phase 2 safety and efficacy study of PRT3789 in combination with pembrolizumab in patients with advanced or metastatic solid tumors and a SMARCA4 mutation Phase 3, randomized, placebo-controlled clinical trial of CAN-2409+prodrug in combination with standard of care external beam radiation (EBRT) for newly diagnosed localized prostate cancer Melanoma and Other Skin Cancers Comparison of ctDNA and hematologic ratios as markers of disease progression in early versus late-stage melanoma: A single-center retrospective study Survival analysis based on markers of progression in melanoma: A single-center comparison of survival in patients with high vs low biomarkers Targetable mutations in cutaneous skin cancers: A comparative study across melanoma, squamous cell carcinoma, basal cell carcinoma, and Merkel cell carcinoma SOURCE Hackensack Meridian John Theurer Cancer Center WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 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ASCOClinical ResultImmunotherapyPhase 1Phase 2

28 May 2025

·pmlive.com

J&J’s Darzalex Faspro recommended by FDA panel of experts for smouldering multiple myeloma

Johnson & Johnson (J&J) has announced that a US Food and Drug Administration (FDA) panel of experts has recommended Darzalex Faspro (daratumumab and hyaluronidase-fihj) as a treatment for smouldering multiple myeloma (SMM), an early precursor of active multiple myeloma (MM). The regulator’s Oncologic Drugs Advisory Committee (ODAC) voted six to two in favour of the benefit-risk profile of the subcutaneous CD38-directed antibody as a monotherapy for adults for high-risk SMM. More than 36,000 new cases of MM, a blood cancer that affects a type of white blood cell called plasma cells, are expected to be diagnosed in the US this year, according to the American Cancer Society. SMM accounts for around 15% of all new cases of the disease and is not generally treated until active MM develops. However, recent evidence has suggested that patients at high-risk for progression to active MM could benefit from earlier therapeutic intervention. Darzalex Faspro, which is co-formulated with Halozyme’s ENHANZE drug delivery technology, is already approved in the US for nine multiple myeloma indications, four of which are for front-line treatment in newly diagnosed patients who are transplant-eligible or ineligible. If approved for this latest indication, the drug would be the first treatment to potentially delay or prevent progression to MM, J&J said. The company’s application was supported by results from the phase 3 AQUILA trial comparing J&J’s drug against active monitoring in 390 SMM patients at high risk of progression. At a median follow-up of 65.2 months, median progression-free survival (PFS) was not reached in the SC Darzalex group versus 41.5 months for active monitoring, with an estimated 60-month PFS rate of 63.1% versus 40.8%, respectively. “Early intervention in high-risk SMM demonstrated a reduction in the risk of progression or death,” said Sen Zhuang, vice president, oncology clinical research, J&J Innovative Medicine, adding that the proactive approach in AQUILA is an example of the company’s “aspiration to get in front of cancer by providing a platform to treat disease before progression to active disease”. The FDA will now review the ODAC’s recommendation as it makes a final decision on Darzalex Faspro in this indication.

Phase 3Drug ApprovalNDAClinical Result

23 May 2025

·firstwordpharma.com

Blenrep comeback continues with EU recommendation, plus a thumbs up for Itovebi

GSK's bid to bring back multiple myeloma therapy Blenrep (belantamab mafodotin) got a major boost on Friday when the antibody-drug conjugate (ADC) received a positive opinion from the EU's drug advisory panel. Also receiving a positive vote from the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) was Roche's breast cancer drug Itovebi (inavolisib). Survival data for the PI3K inhibitor was recently spotlighted in an abstract released ahead of the American Society of Clinical Oncology (ASCO) meeting (see – ASCO25 abstract roundup: Roche's Itovebi cuts risk of death).Autolus' CAR-T cell therapy Aucatzyl (obecabtagene autoleucel) also received a thumbs up from CHMP, as well as mirdametinib, a MEK inhibitor recently acquired by Merck KGaA in its $3.9-billion takeout of SpringWorks Therapeutics. Blenrep is backBlenrep was withdrawn from global markets in 2022 following disappointing results from a confirmatory trial, but after positive readouts from two pivotal Phase III trials — DREAMM-7 and DREAMM-8 — GSK has been working to bring the BCMA-targeted ADC back. Specifically, CHMP recommended Blenrep to treat relapsed or refractory multiple myeloma in combination with bortezomib and dexamethasone (BVd) for adults who have received at least one prior therapy; and in combination with Bristol Myers Squibb's Pomalyst (pomalidomide) plus dexamethasone for patients who have received at least one prior treatment, including BMS's Revlimid (lenalidomide). In DREAMM-7, Blenrep plus BVd achieved a progression-free survival (PFS) of 36.6 months, versus 13.4 months for the comparator regimen of Johnson & Johnson's Darzalex (daratumumab) plus BVd.DREAMM-8 compared Blenrep to bortezomib, both in combination with Pomalyst and dexamethasone. At nearly 22 months follow-up, median PFS was not yet reached with Blenrep compared to 12.7 months in the control arm.In April, the UK became the first country to reauthorise Blenrep. Regulatory applications for the ADC are under review in a dozen other countries, including the US, Switzerland, Japan, China and Canada. The FDA is expected to make a decision by July 23, although there is concern that recent mass layoffs at the FDA could slow down the review process (see – Spotlight On: Could key drug approvals be put at risk of delay by FDA layoffs?).GSK is positioning the drug as a key growth driver, projecting peak annual sales exceeding £3 billion (see – Spotlight On: Can GSK deliver much needed pipeline momentum?).Itovebi impressesItovebi scored a positive opinion for its use in combination with palbociclib and fulvestrant to treat PIK3CA‑mutated, ER‑positive/HER2‑negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.The PI3K inhibitor won a similar approval in the US last October based on data from the Phase III INAVO120 study showing a 57% benefit for the Itovebi triplet on the primary endpoint of PFS compared to palbociclib and fulvestrant alone. Patients achieved PFS of 15 months in the experimental arm versus 7.3 months for placebo.At ASCO, Roche plans to share updated survival data for Itovebi. The abstract revealed that patients who received the triplet experienced a median overall survival of 34 months compared to 27 months for controls, representing a 33% reduction in the risk of death. Additionally, the combination therapy delayed the time to chemotherapy from 12.6 months in the control arm to 35.6 months with Itovebi.Go-ahead for Aucatzyl, mirdametinibA CHMP recommendation also went to Aucatzyl to treat patients aged 26 and older with relapsed or refractory B cell precursor acute lymphoblastic leukaemia (ALL).Autolus' CD19-directed cell therapy was cleared by the FDA in November for a similar indication, based on data from the Phase Ib/II FELIX trial. Of 65 patients with ALL who received the CAR-T, 27 (42%) achieved a complete response (CR) within three months, with a median CR duration of 14.1 months.Meanwhile, Merck KGaA's newly gained mirdametinib received a positive opinion to treat symptomatic, inoperable plexiform neurofibromas (PN) in paediatric and adult patients with neurofibromatosis type 1 (NF1) aged 2 years and above. If fully approved by the European Commission, it will have the brand name of Ezmekly.In February, the MEK inhibitor was approved in the US for the same patient population, where it's marketed as Gomekli.

Clinical ResultDrug ApprovalPhase 3AcquisitionASCO

100 Deals associated with Daratumumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10777	Daratumumab	L01XC24	DB09331

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Immunoglobulin Light-Chain Amyloidosis	European Union	Janssen-Cilag International NV	20 May 2016
Immunoglobulin Light-Chain Amyloidosis	Iceland	Janssen-Cilag International NV	20 May 2016
Immunoglobulin Light-Chain Amyloidosis	Liechtenstein	Janssen-Cilag International NV	20 May 2016
Immunoglobulin Light-Chain Amyloidosis	Norway	Janssen-Cilag International NV	20 May 2016
Multiple Myeloma	United States	Janssen Biotech, Inc.	16 Nov 2015

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Smoldering Multiple Myeloma	NDA/BLA	European Union	Johnson & Johnson	08 Nov 2024
Residual Neoplasm	Phase 3	United States	Janssen Research & Development LLC	26 Apr 2019
Residual Neoplasm	Phase 3	Canada	Janssen Research & Development LLC	26 Apr 2019
Amyloidosis	Phase 3	United States	Janssen Research & Development LLC	10 Oct 2017
Amyloidosis	Phase 3	United States	Xian-Janssen Pharmaceutical Ltd.	10 Oct 2017
Amyloidosis	Phase 3	Japan	Janssen Research & Development LLC	10 Oct 2017
Amyloidosis	Phase 3	Japan	Xian-Janssen Pharmaceutical Ltd.	10 Oct 2017
Amyloidosis	Phase 3	Australia	Xian-Janssen Pharmaceutical Ltd.	10 Oct 2017
Amyloidosis	Phase 3	Australia	Janssen Research & Development LLC	10 Oct 2017
Amyloidosis	Phase 3	Belgium	Xian-Janssen Pharmaceutical Ltd.	10 Oct 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04181827 (CARTITUDE-4, CTgov)	Phase 3	Relapse multiple myeloma \| Multiple Myeloma	419	daratumumab+pomalidomide+bortezomib+dexamethasone (DPd) (Arm A: Standard Therapy: PVd or DPd)	xcgwzceepx(bgfdiawkue) = rqnhloeztl uiakipbehs (xlkipqqqzh, bnrodenbjm - cyomriwxaf) View more	-	20 May 2025
				Autoleucel [Cilta-cel]+JNJ-68284528 (Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]))	xcgwzceepx(bgfdiawkue) = tgotilvhuk uiakipbehs (xlkipqqqzh, fjsilmoeru - buoxiclvqv) View more
NCT03901963 (AURIGA, CTgov)	Phase 3	Residual Neoplasm \| Multiple Myeloma	200	Lenalidomide+Daratumumab (Daratumumab + Lenalidomide)	tqwycdcmda = txukvasxzx lnsgnnthjg (irhwwrlhcl, omqchxovpj - sdrvcjcwkr) View more	-	20 Apr 2025
				Lenalidomide (Lenalidomide)	tqwycdcmda = ahtotmhxho lnsgnnthjg (irhwwrlhcl, hybmhlrlqy - wntmrsztnm) View more
NCT04251065 (CTgov)	Phase 2	T-cell lymphoma refractory \| T-cell lymphoma recurrent \| Immunoblastic Lymphadenopathy ... View more	8	Daratumumab+Dexamethasone+Gemcitabine+Cisplatin (D-GDP)	xzuyczmodx = kwbhkyjzoz ncwccikhpw (vtytdbhiac, zqvhgxarux - pczwqcrutp) View more	-	28 Mar 2025
NCT04824794 (3014-01, NEWS) Manual	Phase 1/2	Multiple Myeloma	84	HexaBody-CD38	nipymosbcw(zziwrtnpvf) = smpcrpdbtt lgpvwnhbiy (vfsiottjtw ) View more	Negative	10 Mar 2025
				subcutaneous daratumumab	nipymosbcw(zziwrtnpvf) = pumxzsdvze lgpvwnhbiy (vfsiottjtw ) View more
NCT04700176 (CTgov)	Phase 2	Relapse multiple myeloma \| Multiple Myeloma \| Refractory Multiple Myeloma	1	Daratumumab+All-trans retinoic acid+Pomalidomide+Dexamethasone (Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A))	ndfekslvgf = pyyposjodr onbsolhjts (awzosfbkjo, acuutcciby - idviaebnsl) View more	-	25 Feb 2025
				Daratumumab+All-trans retinoic acid+Pomalidomide+Dexamethasone (Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B))	ndfekslvgf = atwyadvlkx onbsolhjts (awzosfbkjo, lmrwpjyeyw - zztolgbafs) View more
NCT03710603 (PERSEUS, CTgov)	Phase 3	Multiple Myeloma	709	Lenalidomide+VELCADE+dexamethasone (Velcade Lenalidomide Dexamethasone (VRd))	wgeshkqbvz = ccqnsmzwoa vdlzedzyih (dwfpewornw, rjzuiagnxc - godjzbjdbg) View more	-	24 Dec 2024
				Lenalidomide+Daratumumab+VELCADE+dexamethasone (Daratumumab + VRd (D-VRd))	wgeshkqbvz = epwolzenie vdlzedzyih (dwfpewornw, mdquiiogdt - rcvkdzrhzr) View more
NCT03301220 (AQUILA, ASH2024) Manual	Phase 3	Smoldering Multiple Myeloma	390	Daratumumab	coweojczhh(ncutjolxje) = wbqrasxwfq bcaowuncjd (nsvgsukbha ) View more	Positive	09 Dec 2024
				Active Monitoring	coweojczhh(ncutjolxje) = dimjhvmhmz bcaowuncjd (nsvgsukbha ) View more
NCT03201965 (Andromeda, ASH2024) Manual	Phase 3	Immunoglobulin Light-Chain Amyloidosis First line	388	Daratumumab (DARA) + Bortezomib, Cyclophosphamide, and Dexamethasone (VCd)	qtzhdykcxb(niikjizcso) = xnctktgjmo cfrvxaqglw (xqeilowckm ) View more	Positive	09 Dec 2024
				Bortezomib, Cyclophosphamide, and Dexamethasone (VCd)	qtzhdykcxb(niikjizcso) = mvuhjlmzer cfrvxaqglw (xqeilowckm ) View more
ASH2024	Not Applicable	Multiple Myeloma	-	Daratumumab (Transplant Eligible (TE) patients)	kovlbqkjtp(udhqvotzvq) = rgymirynjz fkhqxlchnj (dklmrnvsok, -6.1 to -0.9) View more	-	09 Dec 2024
				Daratumumab (Transplant Ineligible (TIE) patients)	kovlbqkjtp(udhqvotzvq) = dwbllphggq fkhqxlchnj (dklmrnvsok, -7.6 to -2.1) View more
ASH2024	Not Applicable	Multiple Myeloma	-	Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd)	xrdhmmjvcw(skpwroksqt) = xujtwyqzku rifegbruig (uiwzjzppvp ) View more	-	08 Dec 2024
				DVRd-DR	xrdhmmjvcw(skpwroksqt) = trbxcjmeie rifegbruig (uiwzjzppvp ) View more

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