CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), Hyaluronic acid modulators, ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)

Therapeutic Areas

NeoplasmsImmune System DiseasesCardiovascular Diseases+ [3]

Active Indication

Smoldering Multiple MyelomaImmunoglobulin Light-Chain AmyloidosisMultiple Myeloma+ [13]

Inactive Indication

Monoclonal Gammopathy of Undetermined Significance

Originator Organization

Janssen Global Services LLCGenmab, Inc.

Active Organization

Janssen Research & Development LLCJanssen-Cilag International NV

Halozyme Therapeutics, Inc.

+ [6]

Inactive Organization

Janssen Pharmaceuticals, Inc.

License Organization-

Drug Highest PhaseApproved

First Approval Date

Australia (17 Jul 2017),

Refractory Multiple MyelomaRelapse multiple myeloma

RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan)

Structure/Sequence

Sequence Code 136165

The sequence is quoted from: *****

Sequence Code 9075449L

The sequence is quoted from: *****

Sequence Code 9946743H

The sequence is quoted from: *****

Clinical Trials associated with Daratumumab/Hyaluronidase-fihj

NCT07247097

/ Not yet recruitingPhase 2IIT

ELDORADO: a Randomized Phase II Trial of Elranatamab or Daratumumab in Combination With Lenalidomide, Bortezomib, and Dexamethasone (RVd Lite) in Newly Diagnosed, Transplant Ineligible/Deferred Multiple Myeloma

This research study is being done to compare the efficacy and safety of the combination of elranatamab, lenalidomide, bortezomib, dexamethasone versus the combination of daratumumab, lenalidomide, bortezomib, dexamethasone for patients with newly diagnosed, transplant ineligible/deferred multiple myeloma.

Start Date15 Apr 2026

Sponsor / Collaborator

The Massachusetts General Hospital

[+1]

NCT07110844

/ RecruitingPhase 2IIT

A Phase 2 Clinical Trial of Teclistamab and Daratumumab in Previously Untreated AL Amyloidosis

The purpose of this study is to investigate whether teclistamab-daratumumab combination is effective and safe in AL amyloidosis.
The study treatment is divided into cycles (C) and each cycle is 28 days (D). Study treatment is expected to last 6 months.

Start Date07 Nov 2025

Sponsor / Collaborator

Janssen Pharmaceuticals, Inc.

NCT07075510

/ RecruitingPhase 1/2IIT

A Phase I/II Study of Subcutaneous Daratumumab Administration in the Anterior Upper Thigh Vs Abdomen in Patients With Plasma Cell Disorders

The purpose of this study is to look at the safety, tolerability, and serum concentration of daratumumab administered subcutaneously in the thigh versus the abdomen in patients with plasma cell disorders. Daratumumab is a monoclonal antibody that can attach itself to the CD38 protein on the surface of abnormal plasma cells. Daratumumab can kill the abnormal plasma cells and/or help your immune system find and destroy them. Due to the way daratumumab works, normal cells may also be affected. All reference to the words "study drug" in this consent form will mean Daratumumab.
Daratumumab has been approved by the U.S. Food and Drug Administration (FDA) alone or in combination with other standard of care drugs for treatment of multiple myeloma in both subcutaneous (DARZALEX FASPRO®) and intravenous (DARZALEX®) ways of being delivered. The FDA has also approved the subcutaneous administration of daratumumab combined with other standard of care drugs for patients with light chain (AL) amyloidosis. Subcutaneous means the drug is given by an injection just beneath the skin. Intravenous (IV) means the drug is given as an injection directly into a vein.
Usually when given subcutaneously, the study drug is given by an injection in the abdomen. Having the drug given by subcutaneous injection (underneath the skin of the abdomen) has lessened the IV related side effects and the drug administration by injection is quicker.
However, some patients cannot receive the study drug injections in their abdomen because they find them very painful or have other medical reasons making it difficult to get these injections. The goal of this study is to see if getting the study drug subcutaneously, injected under the skin by a needle, in the patient's upper thigh will have the same results, or better results, as getting the injection in the abdomen. This would therefore, improve patients access to the drug and provide an alternative place to receive the injection of the drug.
This study will take place at University of Maryland Medical Center and there will be about 30 people who will take place in this study here. Dr. Badros is the Sponsor-Investigator of the study. Funding to conduct the study and study drug are being provided by Johnson & Johnson Innovative Medicine (J&J IM).

Start Date23 Oct 2025

Sponsor / Collaborator

University of Maryland Baltimore

[+1]

100 Clinical Results associated with Daratumumab/Hyaluronidase-fihj

100 Translational Medicine associated with Daratumumab/Hyaluronidase-fihj

100 Patents (Medical) associated with Daratumumab/Hyaluronidase-fihj

Literatures (Medical) associated with Daratumumab/Hyaluronidase-fihj

03 Aug 2025·Therapeutic Delivery

May 2025 therapeutic delivery: industry update

Author: Harris, Elaine

This month saw approvals for two products employing Halozyme's Enhanze drug delivery technology (BMS's Opdivo and Johnson and Johnson's DARZALEX FASPRO®). A number of collaborations between industry partners and charities to fight the disease, including Duchenne muscular dystrophy and Epidermolysis Bullosa, have been announced. Successful clinical trial data was disclosed for products employing a wide variety of therapeutic delivery technologies including Perfuse Therapeutics intravitreal implant for glaucoma, Aspen Neurosciences precision delivery of an autologous dopaminergic neuronal precursor cell therapy for Parkinson's disease and Resurge Therapeutics IntraProstatic Drug Elution (IPDE) therapy for prostate cancer.

01 Oct 2024·ANNALS OF HEMATOLOGY

The clinical efficacy of a daratumumab-based regimen in relapsed/refractory acute leukemia: a single-center experience

Article

Author: Li, Jing ; Luo, Lin ; Dai, Yi ; Luo, Jun ; Cheng, Peng ; Wei, Zhenbin

Abstract:

Relapsed/refractory acute leukemia (R/R-AL) is associated with a low remission rate, short survival rate, and poor prognosis. Treating R/R-AL remains challenging as there is no standardized effective regimen; hence, there is a need for efficient therapies. CD38 expression has been observed in acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). Daratumumab is a humanized anti-CD38 monoclonal antibody used to treat multiple myeloma and has been reported to treat R/R-AL safely and effectively. The clinical data of 10 adult patients with R/R-AL who were treated with a daratumumab-based salvage regimen between July 2018 and May 2023 at our center were analyzed retrospectively. Seven AML and three ALL cases were included in the analysis. Seven (70%) patients showed responses to the treatments (complete response [CR], 60%; partial response [PR], 10%). Of the seven responders, three underwent allogenic stem cell transplantation (ASCT), including one who underwent a second ASCT. Among the five patients with R/R AML who had prior exposure to venetoclax, three achieved a therapeutic response (two CR and one PR) when re-treated with venetoclax in combination with daratumumab. The median follow-up time was 6.15 months (0.9–21 months). Overall survival and event-free survival rates at 12 months were 68.6% and 40.0%, respectively. The main adverse events included grade 3 febrile neutropenia (20%) and grade 3 hematological toxicities (60%). The daratumumab-based salvage regimen offers patients with R/R-AL the opportunity of remission with acceptable tolerability, creating the possibility of bridging ASCT.

01 Jun 2023·Clinical pharmacokinetics

Clinical Pharmacokinetics and Pharmacodynamics of Daratumumab

Review

Author: Kim, Kyeongmin ; Phelps, Mitch A

Daratumumab is a fully human, monoclonal immunoglobulin G1 and a first-in-class CD38-targeting drug approved by the US Food and Drug Administration for the treatment of patients with relapsed/refractory and newly diagnosed multiple myeloma or newly diagnosed light-chain amyloidosis. CD38 is heavily expressed on malignant myeloma cells, and daratumumab exerts anti-myeloma activity via immune-mediated mechanisms, direct induction of apoptosis, and immunomodulation. Daratumumab is used as monotherapy or in combination with standard-of-care myeloma therapies, including proteasome inhibitors, immunomodulatory agents, DNA-alkylating agents, and corticosteroids. Following an intravenous infusion, daratumumab exhibits nonlinear pharmacokinetics (PK), as clearance decreases with higher doses and over time because of target-mediated effects. Dosing schedules vary depending on indications and co-administered drugs, but generally daratumumab is administered weekly for 6-9 weeks followed by a less frequent dosing regimen, once every 2-4 weeks. Daratumumab exposure is strongly correlated with efficacy, and the exposure-efficacy relationship follows a maximal effect model, whereas exposure is not correlated with safety endpoints. The approved dose of 16 mg/kg of daratumumab results in the saturation of 99% of the target at the end of weekly dosing in most patients, and high target saturation is maintained over time during the less frequent dosing schedule. Infusion-related reactions are frequently observed in patients given daratumumab, particularly with the first infusion, thus prompting long durations of infusion (~ 7 h) and splitting of the first dose across 2 days. This led to the development of a subcutaneous delivery formulation for daratumumab (Dara-SC). Dara-SC provides a similar efficacy and safety profile to intravenous daratumumab (Dara-IV) but has a much lower rate of infusion-related reactions and a shorter infusion time. Exposure-response relationships for efficacy and safety endpoints were similar between Dara-SC and Dara-IV, and co-administered drugs with either Dara-IV or Dara-SC do not significantly affect daratumumab PK. Except for baseline myeloma type and albumin level, none of the other investigated disease and patient characteristics (renal/hepatic function, age, sex, race, weight, Eastern Cooperative Oncology Group performance status) was identified to have clinically relevant effects on exposure to daratumumab monotherapy or combination therapy regimens. Dara-IV exposure was significantly lower in patients with immunoglobulin G myeloma compared with patients with non-immunoglobulin G myeloma (p < 0.0001) and in patients with a lower albumin level, whereas the overall response rate was similar regardless of the myeloma type and albumin level. Daratumumab dose adjustment is not currently recommended based on disease and patient characteristics.

195

News (Medical) associated with Daratumumab/Hyaluronidase-fihj

06 Jan 2026

·www.biospace.com

Johnson & Johnson submits application to the European Medicines Agency for TECVAYLI®▼ (teclistamab) in combination with DARZALEX® (daratumumab) subcutaneous formulation for patients with relapsed/refractory multiple myeloma

Novel immunotherapy combination regimen brings together two complementary therapies to improve outcomes for people living with multiple myeloma as early as second line 1 The application is supported by data from the Phase 3 MajesTEC-3 study demonstrating a statistically significant improvement in progression-free and overall survival compared to standard treatment 1 Beerse, Belgium, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval for an indication extension of TECVAYLI ® ▼(teclistamab) in combination with DARZALEX ® subcutaneous (daratumumab SC) formulation for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy. The combination of teclistamab and daratumumab SC work in a complementary manner by targeting both BCMA and CD38 to prime and activate the immune system, supporting the potential to improve patient outcomes by enhancing immune-mediated response earlier in the treatment journey. 1 “There remains a critical need for off-the-shelf treatment options that can achieve deep and durable responses at second line, when immune function is better preserved,” said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson Innovative Medicine. “Teclistamab and daratumumab SC is the first off-the-shelf immunotherapy combination to demonstrate significant improvements in progression-free and overall survival in relapsed/refractory multiple myeloma as early as second-line treatment, compared to current standards of care.” The submission is supported by data from the Phase 3 MajesTEC-3 study. The study enrolled 587 patients across two treatment arms: teclistamab and daratumumab SC versus daratumumab SC and dexamethasone with either pomalidomide or bortezomib (DPd/DVd). 1 Results show an 83.4 percent reduction in the risk of disease progression or death compared to standard regimens at nearly three years follow-up (hazard ratio [HR], 0.17; 95 percent confidence interval [CI], 0.12-0.23; P <0.0001). 1 ,2 More than 90 percent of patients who remained progression-free at six months (n=249) remained progression-free at three years. 1 In the study, teclistamab plus daratumumab SC and standard of care comparators had similar rates of Grade 3/4 treatment-emergent adverse events (TEAE) (95.1 percent vs. 96.6 percent). 1 Most common Grade 3/4 events were cytopenia and infection. 1 Infections were observed with teclistamab and daratumumab SC (any grade, 96.5 percent; Grade 3/4, 54.1 percent) and DPd/DVd comparator (any grade, 84.1 percent; Grade 3/4, 43.4 percent). 1 Based on the statistical significance of the results, the Independent Data Monitoring Committee (IDMC) recommended unblinding of the study. 3 Data from the MajesTEC-3 study were recently presented as a late-breaking oral presentation at the 2025 American Society of Hematology (ASH) Annual Meeting, with simultaneous publication in The New England Journal of Medicine . 1,2 Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) for the use of teclistamab and daratumumab SC in combination as a treatment for RRMM to the U.S. Food and Drug Administration (FDA). The FDA has granted Breakthrough Therapy Designation for the combination regimen, which allows for expediting the development and regulatory review of a medicine that is intended to treat a serious or life-threatening condition and is based on preliminary clinical evidence that demonstrates the drug may have substantial improvement over available therapies on a clinically significant endpoint(s). “Johnson & Johnson is committed to redefining what’s possible in multiple myeloma. An integral part of this strategy involves using the right medicines as early as possible and combining and sequencing them to achieve the best outcomes,” said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine. “Today’s submission to the EMA reinforces this approach. Daratumumab has become a cornerstone of care for patients with newly diagnosed multiple myeloma, and by combining it with teclistamab, we see the potential to advance outcomes for relapsed patients as early as second line.” About the MajesTEC-3 Study MajesTEC-3 ( NCT05083169 ) is an ongoing, Phase 3 randomised study evaluating the safety and efficacy of teclistamab plus daratumumab subcutaneous (SC) (n=291) versus investigator’s choice of daratumumab subcutaneous (SC) and dexamethasone with either pomalidomide or bortezomib (n=296) (DPd/DVd) in patients with relapsed/refractory multiple myeloma (RRMM) who have received 1–3 prior lines of therapy. 1,4 The primary endpoint is progression-free survival (PFS) and secondary endpoints include complete response or better (≥CR), overall response rate (ORR), minimal residual disease (MRD) negativity (10⁻⁵ by next-generation sequencing), overall survival (OS), time to worsening of symptoms (MySIm-Q), and safety. 4 The MajesTEC-3 study is a part of the MajesTEC clinical programme, which includes exploring the potential of teclistamab as a combination regimen. 4 About Teclistamab Teclistamab received European Commission (EC) approval in August 2022 for the treatment of patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. 5 In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months. 6 Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody. 7 ,8 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight cancer. Teclistamab is currently being evaluated in several combination studies. 4,7,9,10,11 For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using teclistamab, please refer to the Summary of Product Characteristics at: .▼ In line with EMA regulations for new medicines and those given conditional approval, teclistamab is subject to additional monitoring. 7 About Daratumumab and Daratumumab SC Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease. In August 2012 , Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 618,000 patients worldwide. 12 Daratumumab is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma. 13 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE ® drug delivery technology. 13 CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease. 13 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death. 13 Daratumumab may also have an effect on normal cells. 13 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings across all newly diagnosed multiple myeloma patients, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival. 14,15,16,17,18,19,20,21,22,23 For further information on daratumumab, please see the Summary of Product Characteristics at: About Multiple Myeloma Multiple myeloma is currently an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. 24 ,25 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications. 24,25 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2022, and more than 22,700 patients died. 26 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter. 27,28,29 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage. 30 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . Follow us at . Cautions Concerning Forward-Looking Statements This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of teclistamab and daratumumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Key Search Terms MajesTEC-3 Phase 3 clinical trial TECVAYLI Teclistamab DARZALEX Daratumumab Teclistamab and daratumumab combination TECVAYLI and DARZALEX combination Relapsed and or refractory multiple myeloma (RRMM) Early relapse multiple myeloma Second-line multiple myeloma treatment First relapse therapy for multiple myeloma Treatment resistance in multiple myeloma Progression-free survival (PFS) in multiple myeloma Overall survival (OS) in multiple myeloma Multiple myeloma Bispecific antibody therapy CD38-targeted therapy BCMA-targeted bispecific therapy Combination immunotherapy EMEA haematology pipeline Multiple myeloma innovation Multiple myeloma treatment [1] Mateos M-V, et al. Phase 3 Randomized Study of Teclistamab plus Daratumumab Versus Investigator’s Choice of Daratumumab and Dexamethasone with either Pomalidomide or Bortezomib (DPd/DVd) in patients (pts) with Relapsed Refractory Multiple Myeloma (RRMM): Results of the MajesTEC-3 Study. Oral Presentation #06. American Society of Hematology (ASH) Annual Meeting; 06-09 December, 2025. [2] Costa L, et al. Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. The New England Journal of Medicine. 2025; Full article and supplementary material. Available at: . Last accessed: January 2026. [3] Johnson&Johnson.com. TECVAYLI® plus DARZALEX FASPRO® combination regimen significantly improves progression-free survival and overall survival versus standard of care. Available at: . Last accessed: January 2026. [4] ClinicalTrials.gov. A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-3). Available at: . Last accessed: January 2026. [5] Johnson & Johnson.com. Janssen Marks First Approval Worldwide for TECVAYLI®▼(teclistamab) with EC Authorisation of First-in-Class Bispecific Antibody for the Treatment of Patients with Multiple Myeloma. Available at: . Last accessed: January 2026. [6] Johnson & Johnson.com. European Commission Approves Reduced Dosing Frequency for Janssen’s Bispecific Antibody TECVAYLI®▼ (teclistamab). Available at: . Last accessed: January 2026. [7] European Medicines Agency. TECVAYLI Summary of Product Characteristics. Available at: . Last accessed: January 2026. [8] Moreau P, et al. Teclistamab in Relapsed or Refractory Multiple Myeloma. New England Journal of Medicine. 2022;287(6):494-505. [9] ClinicalTrials.gov. A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (MajesTEC-2). Available at: . Last accessed: January 2026. [10] ClinicalTrials.gov. A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma. Available at: . Last accessed: January 2026. [11] ClinicalTrials.gov. A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma. Available at: . Last accessed: January 2026. [12] J&J Data on File (RF-452129). Number of Patients Treated with DARZALEX Worldwide as of December 2024. [13] Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX ® (Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications. Available at: . Last accessed: January 2026. [14] Moreau P, et al. Bortezomib, Thalidomide, and Dexamethasone With or Without Daratumumab Before and After Autologous Stem-Cell Transplantation for Newly Diagnosed Multiple Myeloma (CASSIOPEIA): A Randomised, Open-label, Phase 3 Study. Lancet. 2019;394(10192):29-38. [15] Facon T, et al. MAIA Trial Investigators. Daratumumab Plus Lenalidomide and Dexamethasone for Untreated Myeloma. New England Journal of Medicine. 2019;380(22):2104-2115. [16] Mateos MV, et al. Overall Survival with Daratumumab, Bortezomib, Melphalan, and Prednisone in Newly Diagnosed Multiple Myeloma (ALCYONE): A Randomised, Open-label, Phase 3 Trial. The Lancet. 2020;395(10218):132-141. [17] Dimopoulos MA, et al. APOLLO Trial Investigators. Daratumumab Plus Pomalidomide and Dexamethasone Versus Pomalidomide and Dexamethasone Alone in Previously Treated Multiple Myeloma (APOLLO): An Open-label, Randomised, Phase 3 Trial. Lancet Oncol. 2021;22(6):801-812. [18] Palladini G, et al. Daratumumab Plus CyBorD for Patients with Newly Diagnosed AL Amyloidosis: Safety Run-in Results of ANDROMEDA. Blood. 2020;2;136(1):71-80. [19] Chari A, et al. Daratumumab Plus Pomalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma. Blood. 2017;130(8):974-981. [20] Bahlis NJ, et al. Daratumumab Plus Lenalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Extended Follow-up of POLLUX, A Randomized, Open-label, Phase 3 study. Leukemia. 2020;34(7):1875-1884. [21] Mateos MV, et al. Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients with Previously Treated Multiple Myeloma: Three-Year Follow-up of CASTOR. Clin Lymphoma Myeloma Leuk. 2020;20(8):509-518. [22] Usmani S Z, et al. Daratumumab + Bortezomib/Lenalidomide/Dexamethasone in Patients with Transplant-Ineligible or Transplant-Deferred Newly Diagnosed Multiple Myeloma: Results of the Phase 3 CEPHEUS Study. Oral Presentation. 21 st International Myeloma Society (IMS) Annual Meeting. September 25 – 28, 2024. [23] Sonneveld P, et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. New England Journal of Medicine. 2024; 390(4):301-313. [24] Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget. 2013;4(12):2186-2207. [25] American Society of Clinical Oncology. Multiple Myeloma: Introduction. Available at: . Last accessed: January 2026. [26] ECIS - European Cancer Information System. Estimates of Cancer Incidence and Mortality in 2022, by Country. Multiple Myeloma. Available at: $0-0$1-All$2-All$4-1,2$3-51$6-0,85$5-2022,2022$7-7$CEstByCountry$X0_8-3$X0_19-AE27$X0_20-No$CEstBySexByCountry$X1_8-3$X1_19-AE27$X1_-1-1$CEstByIndiByCountry$X2_8-3$X2_19-AE27$X2_20-No$CEstRelative$X3_8-3$X3_9-AE27$X3_19-AE27$CEstByCountryTable$X4_19-AE27 . Last accessed: January 2026. [27] Bhatt P, et al. Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse. Curr Oncol. 2023;30(2):2322-2347. [28] Hernández-Rivas JÁ, et al. The Changing Landscape of Relapsed and/or Refractory Multiple Myeloma (MM): Fundamentals and Controversies. Biomark Res. 2022;10(1):1-23. [29] Gavriatopoulou M, et al. Metabolic Disorders in Multiple Myeloma. Int J Mol Sci. 2021;22(21):11430. [30] American Cancer Society. Multiple Myeloma: Early Detection, Diagnosis and Staging. Available at: Last accessed: January 2026. CP-553511 December 2025 CONTACT: Media contact: Jenni Mildon jmildon@its.jnj.com +44 7920 418 552 Investor contact: Lauren Johnson investor-relations@its.jnj.com

Phase 3Clinical ResultDrug ApprovalBreakthrough TherapyLicense out/in

18 Dec 2025

·www.fiercepharma.com

J&J scores FDA nod for subcutaneous lung cancer shot, sharpening its challenge to Tagrisso

Johnson & Johnson's Rybrevant-Lazcluze combo has beat Tagrisso on efficacy, reducing patients’ risk of death by 25% for the first-line treatment of EGFR-mutated non-small cell lung cancer. A year after an FDA rejection, Johnson & Johnson has won approval for a more convenient version of its lung cancer drug Rybrevant to better challenge AstraZeneca’s Tagrisso.Rybrevant Faspro, a subcutaneous formulation of Rybrevant, is now cleared in the same indications as the original intravenous infusion, including its use alongside J&J’s Lazcluze for the first-line treatment of EGFR-mutated metastatic non-small cell lung cancer (NSCLC).Compared with the original Rybrevant, the under-the-skin version reduces the antibody drug’s administration time from several hours to about five minutes, which J&J suggests is more convenient for patients and less burdensome for healthcare resources.“This therapy reduces the physical and emotional burden of lengthy infusions, giving patients and their families the opportunity to reclaim precious moments and focus on living, rather than treatment,” Joelle Fathi, chief healthcare delivery officer at GO2 for Lung Cancer, a patient support group, said in a Dec. 17 statement.The approval arrives a year after FDA inspection findings at a manufacturing facility led to a complete response letter for subcutaneous Rybrevant, which was developed using Halozyme Therapeutics’ Enhanze drug delivery technology.J&J hopes the latest Faspro offering can repeat the success of the company’s blockbuster multiple myeloma drug Darzalex Faspro. But, unlike the almost-unchallenged anti-CD38 drug, Rybrevant faces an uphill fight against AZ’s Tagrisso and the dominant EGFR inhibitor’s latest combination with chemotherapy.J&J’s Rybrevant-Lazcluze combo already beat Tagrisso on efficacy, reducing patients’ risk of death by 25% in the phase 3 Mariposa trial in first-line EGFR-mutated NSCLC. But Tagrisso’s convenience as a once-daily tablet and its well-understood safety profile could still make persuading doctors to switch to Rybrevant-Lazcluze an arduous process for J&J. On the safety side, Rybrevant Faspro is an improvement from infused Rybrevant, thanks to its ability to reduce the rate of administration-related reactions to 13% from 66%, according to results from the phase 3 Paloma-3 trial. The study compared the two versions of amivantamab in their separate combinations with Lazcluze in previously treated EGFR-mutated NSCLC.Venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism, was also lower, at 11%, for the combo with subcutaneous Rybrevant, versus 18% observed in patients who received the intravenous formulation in Paloma-3.But VTE could be an Achilles’ heel of J&J’s Rybrevant regimen in its ongoing battle against Tagrisso. In the Mariposa trial in the first-line setting, intravenous Rybrevant and Lacluze were linked to a 36% VTE rate, whereas only 9% of Tagrisso takers experienced VTE. As a result, prophylactic anticoagulation is recommended for the first four months of treatment with Rybrevant or Rybrevant Faspro.To prop up Tagrisso’s efficacy, AZ last year won the FDA’s approval for its use alongside chemotherapy after the phase 3 Flaura2 trial showed that the combo reduced the risk of disease progression or death by 38% compared with Tagrisso alone. Then, earlier this year, AZ reported that the trial met its overall survival endpoint, with the combo boasting a 23% death risk reduction versus Tagrisso monotherapy.J&J has argued that patients do not want to take chemotherapy upfront given its toxicity. Now, with Rybrevant Faspro, the administration time of the J&J regimen is also shorter than chemo, which the company said could take up to an hour. Rybrevant Faspro may also hold an efficacy advantage over the original Rybrevant. In the Paloma-3 trial, the two formulations showed similar pharmacokinetic results as measured by amivantamab levels in the blood. But overall survival data were surprisingly better for patients treated with Rybrevant Faspro, with a 38% death risk improvement.J&J has hypothesized that subcutaneous absorption of the drug may potentially enhance immune-mediated anticancer activity. This survival finding was drawn from the second-line setting, and it was not included in Rybrevant Faspro’s label.Before the latest nod, Rybrevant and Lazcluze together brought in $136 million in U.S. sales in the third quarter, versus $139 million in the second quarter and $113 million in the first.In the first nine months of 2025, Tagrisso increased sales by 11% year over year in the U.S., reaching $2.2 billion, as AZ touted the Flaura2 regimen as the leading combo in first-line EGFR-mutated NSCLC.

Phase 3Clinical ResultDrug ApprovalADC

15 Dec 2025

·firstwordpharma.com

Busy FDA: Stellar data hands J&J a priority voucher, RWE policy shift and a trio of approvals

On what turned out to be a busy Monday at the FDA, the US regulator awarded a national priority voucher to a multiple myeloma treatment regimen from Johnson & Johnson following impressive Phase III results, while also loosening longstanding restrictions on real-world evidence (RWE) for medical device applications — and hinting it may do the same for drugs and biologics.Tecvayli-Darzalex voucherIn a nod to its clinical potential in multiple myeloma, Johnson & Johnson's combination of anti-BCMA bispecific Tecvayli (teclistamab-cqyv) plus Darzalex Faspro (daratumumab/hyaluronidase-fihj) became the latest recipient of a national priority voucher from the FDA, after the agency took notice of the Phase III MajesTEC-3 study results and liked what it saw."Within hours of the trial results being published in the American Society of Hematology (ASH) conference programme, FDA leaders read the study, consulted with internal experts, and the following day contacted the company to discuss a national priority voucher," FDA Commissioner Marty Makary said.Results from the trial, presented at ASH last week, showed that the Tecvayli-Darzalex Faspro combo achieved a three-year progression-free survival (PFS) rate of over 83%, compared to around 30% for the comparator arm (see – Spotlight On: J&J's eye-popping MajesTEC-3 data a win for Tecvayli, MM bispecifics).The latest voucher brings the total number of products receiving an award under the Commissioner's National Priority Voucher (CNPV) pilot programme to 16. The programme is designed to speed up reviews for products that are deemed "aligned with US national priorities." Review decisions are targeted for completion within one to two months after an application is submitted. The first product to win approval under the programme — the US-manufactured version of the antibiotic Augmentin XR (amoxicillin-clavulanate potassium) — was announced last week.RWE policy shiftMeanwhile, the FDA is also overhauling its approach to RWE, removing a major barrier that has historically limited its use in regulatory submissions. Previously, RWE required identifiable individual patient data, but the agency said Monday that de-identified datasets can now provide meaningful insights.For medical devices, the FDA will accept RWE without requiring that identifiable individual patient data collected from real-world data sources always be submitted in a marketing submission; it will "consider" updating its drug and biologic guidance to match..The agency said it is "responding to the position of many sponsors and data scientists that meaningful information can be extracted from some big data sources without private, individual information."While RWE has been more widely applied in medical device approvals, the restriction has limited the use of RWE in drug applications. Since 2016, the agency said just 35 drugs, biologics or vaccines have incorporated RWE into their submissions. The FDA will now evaluate RWE submissions on a case-by-case basis.The policy change unlocks access to massive de-identified databases that were previously unusable for regulatory submissions, including national cancer registries like the National Cancer Institute's Surveillance, Epidemiology, and End Results; hospital system databases; insurance claims data; and electronic health record networks, containing millions of patient records.New Enhertu, PCSK9 nodsBeyond policy shifts and priority vouchers, the FDA also handed down a pair of traditional approval Monday. The most notable went to AstraZeneca and Daiichi Sankyo's Enhertu (fam-trastuzumab deruxtecan-nxki). The HER2-targeting antibody-drug conjugate can now be used in combination with Roche’s Perjeta (pertuzumab) to treat adults with treatment-naïve, unresectable or metastatic HER2-positive breast cancer. For more details on the approval, see FDA greenlights Enhertu's move into first-line breast cancer.Meanwhile, third-generation PCSK9 inhibitor Lerochol (lerodalcibep-liga), developed by LIB Therapeutics, was cleared to help reduce LDL cholesterol (LDL-C) in adults with hypercholesterolaemia, including heterozygous familial hypercholesterolaemia.The filing was backed by data from the Phase III LIBerate programme, which enrolled over 2900 patients across diverse populations, including those with cardiovascular disease as well as those with heterozygous or homozygous familial hypercholesterolaemia.In clinical testing, Lerochol achieved sustained LDL-C reductions of 60% or more in patients with or at high risk of cardiovascular disease, and 50% or more in those with HeFH who have more severe LDL-C elevations. The drug was generally well tolerated with no treatment-related serious adverse events reported in long-term extension studies.Lerochol is expected to reach US pharmacies in spring 2026, initially as a pre-filled syringe, with an autoinjector device following later in the year. The company has submitted applications for approval in Europe as well, with a decision anticipated by mid-2026.Friday Cardamyst approvalLate on Friday, the FDA also approved a nasal spray that patients can self-administer at the first signs of paroxysmal supraventricular tachycardia (PSVT).Milestone Pharmaceuticals said the FDA's green light of the rapid-acting calcium channel blocker Cardamyst (etripamil), the company's first product, represents a breakthrough for patients who have endured the anxiety of never knowing when their heart rate might suddenly spike to 150-200 beats per minute, causing severe palpitations, shortness of breath and debilitating distress that could last for several hours.In the Phase III RAPID trial published in The Lancet, patients using Cardamyst were twice as likely to convert from supraventricular tachycardia to sinus rhythm within 30 minutes compared to placebo (64% versus 31%), and did so more than three times faster, with a median conversion time of 17 minutes versus 54 minutes. The approval draws on clinical data from over 1800 participants and 2000 PSVT episodes.Side effects were limited to mild, transient nasal discomfort, nasal congestion, rhinorrhoea, throat irritation, and epistaxis. Fewer than 2% of participants discontinued due to adverse events.CEO Joseph Oliveto said the company's "at-the-ready treatment option…addresses the unpredictable impact of PSVT by offering patients the freedom to manage episodes anytime and anywhere."

Phase 3Clinical ResultDrug ApprovalASH

100 Deals associated with Daratumumab/Hyaluronidase-fihj

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Smoldering Multiple Myeloma	United States	Janssen Biotech, Inc.	06 Nov 2025
Smoldering Multiple Myeloma	United States	Johnson & Johnson	06 Nov 2025
Immunoglobulin Light-Chain Amyloidosis	United States	Janssen Biotech, Inc.	15 Jan 2021
Multiple Myeloma	United States	Janssen Biotech, Inc.	01 May 2020
Refractory Multiple Myeloma	Australia	Janssen-Cilag Pty Ltd.	17 Jul 2017
Relapse multiple myeloma	Australia	Janssen-Cilag Pty Ltd.	17 Jul 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Monoclonal Gammopathy of Undetermined Significance	Phase 2	United States	Janssen LP	26 Sep 2025
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma	Phase 2	United States	Janssen LP	25 May 2023
Residual Neoplasm	Phase 2	United States	Janssen LP	25 May 2023
Acute Myeloid Leukemia	Phase 1	United States	Janssen Research & Development LLC	19 Sep 2024
Adult Acute Lymphocytic Leukemia	Phase 1	United States	Janssen Research & Development LLC	19 Sep 2024
Anemia, Aplastic	Phase 1	United States	Janssen Research & Development LLC	19 Sep 2024
Bone marrow transplant rejection	Phase 1	United States	Janssen Research & Development LLC	19 Sep 2024
Chronic Myelogenous Leukemia	Phase 1	United States	Janssen Research & Development LLC	19 Sep 2024
Hodgkin's Lymphoma	Phase 1	United States	Janssen Research & Development LLC	19 Sep 2024
Myelodysplastic Syndromes	Phase 1	United States	Janssen Research & Development LLC	19 Sep 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05083169 (MajesTEC-3, ASH2025) Manual	Phase 3	Refractory Multiple Myeloma	587	Teclistamab + Daratumumab	hquqpykepf(ojogazyfdv) = eqwhrjcokv xmikjczyzr (pkepxfesiw ) View more	Positive	09 Dec 2025
				Daratumumab + Dexamethasone + either Pomalidomide or Bortezomib	hquqpykepf(ojogazyfdv) = fjzqakwizq xmikjczyzr (pkepxfesiw ) View more
NCT05511428 (CTgov)	Phase 4	Multiple Myeloma	20	Interview+Daratumumab and Hyaluronidase-fihj	qlwfsmgrbv(wrzraqczpp) = yaxacehyrr muijunyljo (xtmytnsasq, 10.5) View more	-	21 Nov 2025
NCT05083169 (MajesTEC-3, Company_Website) Manual	Phase 3	Multiple Myeloma Second line \| Last line \| Third line	-	Daratumumab Injection（Subcutaneous Injection）+Teclistamab	luvquscobd(vuvbdjnjup) = Reaching the endpoint zozlwdcixr (bpfdtyhjkj ) Met View more	Positive	16 Oct 2025
				standard of care
NCT03710603 (PERSEUS, ASCO2025 \| PRNewswire) Manual	Phase 3	Multiple Myeloma First line	709	daratumumab+bortezomib+lenalidomide+dexamethasone (Achieved sustained (≥12 mo) MRD neg (10^-5))	lsjnxocacs(qmqephasjg) = agmykbbwmh molstyzjbp (puvpnfonhp, NE - NE) View more	Positive	30 May 2025
				bortezomib+lenalidomide+dexamethasone (Achieved sustained (≥12 mo) MRD neg (10^5))	lsjnxocacs(qmqephasjg) = rurbvaymnh molstyzjbp (puvpnfonhp, NE - NE) View more
NCT03652064 (CEPHEUS, ASCO2025) Manual	Phase 3	Multiple Myeloma First line HRCA del(17p) \| HRCA t(4;14) \| HRCA t(14;16) ... View more	395	Daratumumab + bortezomib + lenalidomide + dexamethasone (HiR)	mgrhlxvsuq(itulrybltr) = fzraergtnk ebpyrrkllv (wqkhikzfbb ) View more	Positive	30 May 2025
				Bortezomib + lenalidomide + dexamethasone (HiR)	mgrhlxvsuq(itulrybltr) = hxmewyviuk ebpyrrkllv (wqkhikzfbb ) View more
NCT03710603 (PERSEUS, CTgov)	Phase 3	Multiple Myeloma	709	Lenalidomide+VELCADE+dexamethasone (Velcade Lenalidomide Dexamethasone (VRd))	khknimbsyp = vjzokdisdi jeaqtikmnt (paxxngcesm, pvwiixifvv - celcgkdcgx) View more	-	24 Dec 2024
				Lenalidomide+Daratumumab+VELCADE+dexamethasone (Daratumumab + VRd (D-VRd))	khknimbsyp = pvxkyfdipc jeaqtikmnt (paxxngcesm, dxnjeuakbe - fprqtqbrpt) View more
NCT03201965 (Andromeda, ASH2024 \| EINPresswire) Manual	Phase 3	Immunoglobulin Light-Chain Amyloidosis First line	388	Daratumumab (DARA) + BortezomibBortezomib, CyclophosphamideCyclophosphamide+Dexamethasone (VCd)	wpezyxabcn(vavmpmgyon) = shrqvagibl tcqbvsxcfd (hvmhqwghih ) View more	Positive	09 Dec 2024
				Bortezomib+Cyclophosphamide+Dexamethasone (VCd)	wpezyxabcn(vavmpmgyon) = bxadmviweq tcqbvsxcfd (hvmhqwghih ) View more
NCT03652064 (CEPHEUS, PRNewswire) Manual	Phase 3	Multiple Myeloma First line	396	DARZALEX FASPRODARZALEX FASPRO® + bortezomib, lenalidomidebortezomib, lenalidomide and dexamethasonedexamethasone (D-VRd)	ktfrxwpycs(hifbybgykj) = tdaaelkxco hsmoxycaop (rqsqbctxue ) View more	Positive	30 Sep 2024
				bortezomib, lenalidomidebortezomib, lenalidomide and dexamethasone (VRd)	ktfrxwpycs(hifbybgykj) = sclzmcuiws hsmoxycaop (rqsqbctxue ) View more
NCT03652064 (CEPHEUS, Company_Website) Manual	Phase 3	Multiple Myeloma First line	396	DARZALEX FASPRO+bortezomib+ lenalidomide + dexamethasone	loymnlkmde(cwnpewmlzi) = neqanoeurb mktjgijvoz (ybrurqcfzq ) View more	Positive	27 Sep 2024
				Bortezomib+ Lenalidomide+ Dexamethasone	loymnlkmde(cwnpewmlzi) = cfrzbhynyw mktjgijvoz (ybrurqcfzq ) View more
NCT03412565 (PLEIADES, FDA_CDER) Manual	Phase 2	Relapse multiple myeloma \| Refractory Multiple Myeloma	66	DARZALEX FASPRO-Kd	brycmjrfbu(dsgnuihavg) = dwdwhklrzy umeuxabfgn (xigsfipomo, 73.9 - 92.5) View more	Positive	30 Jul 2024

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