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Last update 17 Mar 2026

Lenalidomide

Last update 17 Mar 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Degradable Molecular Glue

Synonyms

1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline, 3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione, CMIO-LLD

+ [18]

Target

CK1α x CRBN x IKZF1 x IKZF3

Action

inhibitors, modulators, degraders

Mechanism

CK1α inhibitors(casein kinase 1 alpha 1 inhibitors), CRBN modulators(Cereblon modulators), IKZF1 degraders(DNA-binding protein Ikaros degraders)

Therapeutic Areas

NeoplasmsImmune System DiseasesCongenital Disorders+ [8]

Active Indication

Large B-cell lymphomaMarginal Zone B-Cell LymphomaAdult T-Cell Leukemia-Lymphoma+ [75]

Inactive Indication

Aase Smith Syndrome 2Acute Kidney Injuryacute leukemia+ [123]

Originator Organization

Celgene Corp.

Active Organization

Millennium Pharmaceuticals, Inc.

Incyte Corp.

Bristol Myers Squibb Co.

+ [34]

Inactive Organization

Celgene International II SARL

Excel Pharma Studies, Inc.

Onyx Therapeutics, Inc.

+ [17]

License Organization

Starton Therapeutics, Inc.

Xencor, Inc.

Bend Bioscience LLC

+ [1]

Drug Highest PhaseApproved

First Approval Date

United States (27 Dec 2005),

Myelodysplastic Syndromes

RegulationOrphan Drug (United States), Priority Review (China), Orphan Drug (Japan), Special Review Project (China)

Structure/Sequence

Molecular FormulaC13H13N3O3

InChIKeyGOTYRUGSSMKFNF-UHFFFAOYSA-N

CAS Registry191732-72-6

1,301

Clinical Trials associated with Lenalidomide

NCT07029776

/ Not yet recruitingPhase 2

A Phase 2 Study Exploring the Use of Bispecific Antibodies to Improve Progression Free Survival in Patients With High-Risk Newly Diagnosed Multiple Myeloma (MMulti-Immune HR)

The purpose of this research is to learn whether using teclistamab and talquetamab at different time points will improve survival in participants with high-risk Multiple Myeloma (MM).
The treatment on this study will consist of Induction chemotherapy and stem cell collection, Immunotherapy 1 chemotherapy and Immunotherapy 2 chemotherapy. For participants whose testing show they are Minimal Residual Disease (MRD) positive (still have myeloma cells present in the bone marrow testing), a Melphalan-based stem cell transplant will be performed. For participants whose testing show they are MRD negative, the stem cell transplant will not be performed. All participants will go on to receive Immunotherapy 3 chemotherapy, Immunotherapy 4 chemotherapy, and Maintenance therapy.

Start Date01 Jul 2026

Sponsor / Collaborator

Janssen Research & Development LLC

NCT06348147

/ SuspendedPhase 2

An Attenuated Schedule Dara-RVd Induction for Patients With Newly Diagnosed Multiple Myeloma Who Are Eligible for Autologous Stem Cell Transplantation

This Phase II hybrid decentralized trial will examine the effect of daratumumab-based quadruplet induction therapy administered at an attenuated schedule in subjects with newly diagnosed multiple myeloma (NDMM) who are eligible for standard-of-care autologous stem cell transplantation (ASCT). Daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVd) have recently become a standard induction regimen for patients with NDMM who are eligible for ASCT in the United States. As implemented in clinical trials, Dara-RVd involves twice weekly bortezomib administration, which is inconvenient for patients and may result in increased rates of limiting toxicity, such as peripheral neuropathy. Adoption of alternate schedules involving once-weekly bortezomib is common in real-world practice, however a paucity of prospective data supporting this practice exists.
This study examines the efficacy of an attenuated Dara-RVd schedule involving once-weekly bortezomib dosing.

Start Date01 Jul 2026

Sponsor / Collaborator

Lineberger Comprehensive Cancer Center

NCT07428369

/ Not yet recruitingPhase 2/3

A Phase 2/3, Open-Label, Randomized Study of Linvoseltamab, Bortezomib and Lenalidomide (Linvo-VR) With and Without Autologous Stem Cell Transplantation (ASCT) Vs Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) in Transplant-Eligible Participants With Newly Diagnosed Multiple Myeloma

This study is focused on participants with Newly Diagnosed Multiple Myeloma (NDMM) who are eligible for high dose chemotherapy followed by Autologous Stem Cell Transplantation (ASCT).
This study is evaluating a drug called linvoseltamab in combination with standard therapies for multiple myeloma called bortezomib (V) and lenalidomide (R). This combination is abbreviated as Linvo-VR.
The aim of this study is to compare how well Linvo-VR, with and without ASCT, treats myeloma to how well the current standard of care regimen for NDMM treats myeloma. That current standard of care regimen includes the drugs daratumumab (D), bortezomib (V), lenalidomide (R), and dexamethasone (d). This combination is referred to as DVRd. The study is also evaluating if Linvo-VR treats myeloma well enough that ASCT is no longer needed with the first myeloma treatments.
The study is looking at several other research questions, including:
* What side effects may happen from taking linvoseltamab
* How much linvoseltamab is in the blood at different times
* Whether the body makes antibodies against the linvoseltamab (which could make the drug less effective or could lead to side effects)

Start Date05 Jun 2026

Sponsor / Collaborator

Regeneron Pharmaceuticals, Inc.

100 Clinical Results associated with Lenalidomide

100 Translational Medicine associated with Lenalidomide

100 Patents (Medical) associated with Lenalidomide

7,794

Literatures (Medical) associated with Lenalidomide

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Indirect treatment comparison of DVRd plus DR maintenance (PERSEUS study) versus DVTd or VTd with or without lenalidomide maintenance in transplant-eligible patients with previously untreated multiple myeloma

Article

Author: Einsele, Hermann ; Facon, Thierry ; Nair, Sandhya ; Dimopoulos, Meletios A. ; He, Jianming ; Caillot, Denis ; Sonneveld, Pieter ; Zweegman, Sonja ; Ammann, Eric ; Spencer, Andrew ; Nobrega, Marjorie ; Broijl, Annemiek ; Perrot, Aurore ; Schjesvold, Fredrik ; Gay, Francesca ; Boccadoro, Mario ; Hajek, Roman ; Rodriguez-Otero, Paula ; Hulin, Cyrille ; Sitthi-Amorn, Anna ; Rowe, Melissa ; Leleu, Xavier ; Mina, Roberto

AIMS:

To compare the effectiveness of induction and consolidation with daratumumab, bortezomib, lenalidomide, and dexamethasone (DVRd) plus maintenance therapy with daratumumab and lenalidomide (DR) with 2 treatment regimens that are widely used for transplant-eligible newly diagnosed multiple myeloma (TE NDMM): bortezomib, thalidomide, and dexamethasone (VTd) or daratumumab-VTd (DVTd) followed by observation (Obs) or lenalidomide maintenance.

MATERIALS AND METHODS:

Individual patient-level data from the PERSEUS (NCT03710603) and CASSIOPEIA (NCT02541383) trials were used to compare DVRd + DR with VTd + Obs and with DVTd + Obs. Inverse probability of treatment weighting was used to adjust for differences in baseline patient characteristics between the two trials; inverse probability of censoring weighting was used to adjust for the second randomization of CASSIOPEIA. Data from the CASSIOPEIA and Myeloma XI (EudraCT 2009-010956-93) trials were combined to model outcomes associated with lenalidomide (R) maintenance following induction with DVTd or VTd.

RESULTS:

DVRd + DR showed superior progression-free survival compared with DVTd + Obs (hazard ratio, 0.39 [95% CI = 0.26-0.59]), VTd + Obs (0.17 [95% CI = 0.12-0.25]), DVTd + R (0.62 [95% CI = 0.41-0.92]), and VTd + R (0.29 [95% CI = 0.18-0.43]). Sensitivity analyses showed results were consistent with the base case.

LIMITATIONS:

The indirect treatment comparison was unanchored due to a lack of common comparators and relied on external data from the Myeloma XI trial to model outcomes associated with DVTd or VTd followed by R maintenance. Despite best efforts to identify and adjust for important treatment effect modifiers, there is a potential for residual confounding.

CONCLUSIONS:

Findings from this study suggest that DVRd followed by DR maintenance offers superior survival outcomes compared with current standards of care in TE patients with NDMM.

31 Dec 2026·Hematology

Neutrophil extracellular trap-related genes in PTCL: identification, prognosis and drug interaction prediction via bioinformatics-machine learning

Article

Author: Chen, Jing ; Cheng, Fanjun ; Fang, Jun

OBJECTIVE:

This study aimed to identify neutrophil extracellular trap-related genes (NET-RGs), explore their prognostic significance, and predict drug interactions in peripheral T-cell lymphoma (PTCL).

METHODS:

Differentially expressed NET-RGs (DE-NRGs) between PTCL and normal tissues were screened. Functional enrichment analysis was conducted. Bioinformatics and machine learning were used to identify hub genes and assess their diagnostic value. Univariate and multivariate analyses were used to evaluate prognostic roles. Correlation and immune infiltration analyses were performed to explore relationships with the tumor microenvironment (TME). Clinical data were collected from PTCL patients who received potential agents (lenalidomide) as first-line treatment.

RESULTS:

A total of 31 DE-NRGs were identified (18 upregulated and 13 downregulated), enriched in inflammatory response, extracellular matrix organization, and infection involvement. Four hub genes (AKT2, MAPK14, IRF1, and TNF) were identified as effective PTCL diagnostic markers. Higher AKT2/MAPK14 expression correlated with poorer overall survival (OS), while elevated TNF expression associated with better OS; AKT2 and TNF independently predicted OS. These genes were implicated in modulating TME remodeling. Potential therapeutic agents (e.g. capivasertib, lenalidomide) were predicted, and lenalidomide may represent a feasible initial treatment option for PTCL, with an objective response rate (ORR) of 40.0% and a maximum survival duration exceeding 50 months.

CONCLUSION:

NET-RGs play crucial roles in diagnosis, prognosis, and TME regulation, and lenalidomide, a putative TNF-targeting agent, may represent a feasible initial treatment option in PTCL.

01 Dec 2026·JOURNAL OF MOLECULAR MEDICINE-JMM

Anti-myeloma activity of the CXCR4 antagonist WZ811

Article

Author: Suroviakova, Katarina ; Sedlak, Jan ; Jakubikova, Jana ; Valuskova, Zuzana ; Strizova, Anna ; Marinkovicova, Maria Elisabeth ; Csicsatkova, Nikoleta ; Cholujova, Danka

Abstract:

The CXCR4-CXCL12 axis is crucial for the interaction between malignant plasma cells (PC) and their microenvironment in multiple myeloma (MM). Here, we show that CXCR4 expression is upregulated in MM cell lines and PCs during both premalignant and active stages of MM, compared to normal PCs from healthy donors. The CXCR4 antagonist WZ811 reduced the viability of MM PCs and cell lines, while tumor microenvironment cells from both MM patients and healthy donors exhibited significant resistance. In vivo, WZ811 significantly reduced tumor burden and improved survival. WZ811-mediated MM cell death involved disruption of mitochondrial transmembrane potential, externalization of transmembrane phosphatidylserine, activation of caspases, increased levels of autophagic proteins, and an increase in G 0 /G 1 phase of the cell cycle. WZ811 also eliminated the MM stem cell-like side population, though slight resistance was observed with stromal cells. Additionally, WZ811 increased levels of CXCL12 and extracellular matrix molecules collagen IV and laminin in MM cells. Combining WZ811 with anti-MM agents showed synergism with doxorubicin, dexamethasone, bortezomib, lenalidomide, and pomalidomide, while antagonism was observed with carfilzomib, supporting the clinical assessment of WZ811 in MM.

Key messages:

WZ811 reduced the viability of myeloma primary cells and cell lines.WZ811 reduced tumor burden and improved survival in vivo xenograft model.WZ811 mechanisms involved apoptotic and autophagic cell death.WZ811 eliminated the MM stem cell-like side population.WZ811 synergized with DOX, DEX, BTZ, LEN, and POM.

1,095

News (Medical) associated with Lenalidomide

11 Mar 2026

·www.fiercepharma.com

As Lilly flourishes in Q4, peer projections signal looming sector slowdown in 2026

As companies reported their fourth- quarter and 2025 sales, guidances for 2026 were particularly noteworthy as most companies are projecting a decline in growth. Twelve months ago, drugmakers came roaring into 2025, fueled by a massive year of growth that peaked in the fourth quarter of 2024. Now, the momentum has dissipated, and most companies are bracing for a slowdown in sales heading into 2026. In fact, over the last few weeks of earnings reports, drugmakers' financial results were less noteworthy than their guidances. Of 25 companies with quarterly revenue of at least $2 billion that had reported through March 5, just five projected that their sales would grow at a higher rate in 2026 than in 2025, with each of those increases slight.The pharmas offered a variety of reasons—macro and micro—for their pessimistic 2026 projections. Several mentioned pricing effects related to the Inflation Reduction Act (IRA), as well as U.S. President Donald Trump’s most-favored-nation plan and his threats of tariffs on pharmaceutical products. An anticipated decline in vaccine sales, linked to a demand shortfall in the U.S., also plays into the computation for several companies, while many others are dealing with the loss of exclusivity (LOE) of blockbuster products.The drugmaker with the most surprising projection was Novo Nordisk, which recently stunned analysts with an estimated revenue decline of between 5% and 13% in 2026.The dismal estimate is difficult to fathom, coming as the company still is awash in the success of its groundbreaking metabolic medicines Ozempic and Wegovy. The combined sales of the semaglutide drugs came out to $31.2 billion last year, up 15% from 2024. Additionally, the Danish company reported strong launch metrics last month for its highly anticipated GLP-1 obesity pill.The first signs of a sales shortfall, however, came in the third quarter of last year when Novo reported a revenue increase of just 5%. That came after 12 straight quarters of double-digit year-over-year growth. Then, in the fourth quarter of 2025, Novo’s sales declined by 8% year over year. Novo CEO Mike Doustdar blamed “unprecedented pricing pressures” for his company's anticipated 2026 sales slide, citing “intensifying competition” and the MFN pricing deal the company struck with the Trump administration last fall. Other drugmakers projecting a revenue slide in 2026 include Bayer, Biogen, Bristol Myers Squibb, Pfizer and Teva. After a 1% drop in sales from its pharma business in the fourth quarter, Bayer is now expecting (PDF) a decline between 0% and 3% in 2026, largely attributed to declining sales of eye disease treatment Eylea and blood thinner Xarelto. Both drugs were already in decline last year, but the effect will be more pronounced in 2026, the company warned. The good news is that Bayer expects taking a big hit in 2026 will set the pharma business up for a mid-single-digit sales increase in 2027, which should persist to the end of the decade. Following five straight years of revenue declines, Biogen saw a 2% increase in its sales in 2025. But the company expects the gain to be short-lived, projecting a 5% revenue decline at the midpoint of its 2026 guidance. Headwinds to growth include erosion in Europe for multiple sclerosis treatment Tecfidera and the recent introduction of biosimilar competition for another of its MS drugs, Tysabri. Those effects impacted sales in the fourth quarter of last year, which were down 7%.For its part, BMS is projecting (PDF) a 3% decline at the midpoint of its 2026 revenue projection. If that forecast holds true, it would mark the second straight year for BMS with a drop in annual sales, which landed at $48.3 billion in 2024 and slipped ever-so-slightly to $48.2 billion in 2025. The company cited declining sales of its legacy products, which were down 16% in 2025, for the revenue decline. That roster of aging products includes blood cancer blockbusters Revlimid and Pomalyst. Declining sales of generic Revlimid also account for an expected overall revenue slide for Teva this year. The Israeli company projects it will make $1.1 billion less from its Revlimid copycat and is projecting a 4% decline overall at the midpoint of its 2026 revenue guidance. This comes after three years of annual sales increases for the company, including a 4% bump in 2025. Another factor in the expected contraction for Teva is declining sales from its generics business as the company continues its makeover favoring development of its innovative portfolio of products.As for Pfizer, which revealed (PDF) its guidance in December of last year, the company similarly expects a 3% year-over-year sales decline at the midpoint of its 2026 revenue window, which was $61 billion. It would be Pfizer’s second straight year with a sales decline from $63.6 billion in 2024 and $62.5 billion in 2025. The company referenced an anticipated $1.7 billion decline in sales of its COVID products—from $6.7 billion in 2025 to a projection of $5 billion in 2026. It also expects to sustain a $1.5 billion hit from exclusivity losses on certain products this year. Pfizer also warned that its down revenue trajectory is likely to continue as those LOEs escalate in the coming years—to $3 billion-plus in 2027 and $6 billion-plus in 2028, according to the company. Just 6 companies expect increased growth in 2026Companies that are projecting higher growth in 2026 compared to 2025 are AbbVie, Johnson & Johnson, Merck, Sanofi, Vertex and Viatris, although each expects only a slight increase.AbbVie anticipates continuing its roll with autoimmune juggernauts Skyrizi and Rinvoq, projecting combined sales of the drugs will exceed $31 billion in 2026, compared to $25.8 billion last year. The company predicts its overall revenue will reach $67 billion this year, which would represent 9.5% growth compared to last year’s figure of 8.6%. It’s a significant turnaround considering the hit the company took in 2023 with the LOE of Humira. In that year, AbbVie’s sales fell by 6.4%. Meanwhile, J&J, which has seen revenue increase at a higher rate each year since its 2023 spinoff of consumer health business Kenvue, is projecting sales in 2026 to come in at between $99.5 billion and $101.08 billion, easily topping the company’s pre-spinoff record haul of $94.9 billion in 2022. Also within reach for J&J in 2026 is the single-year, industry revenue record of $100.3 billion, which Pfizer achieved during the height of the pandemic in 2022 thanks to $56.7 billion in sales of its COVID products. Viatris is also guiding to an increase in revenue, from $14.3 billion in 2025 to $14.7 billion at the midpoint of its 2026 estimate. While this projected increase is slight, it is significant as it comes after four straight years of revenue declines, starting with $17.9 billion in 2021 following its formation as a merger between Mylan and Pfizer’s former generics unit Upjohn. Vertex is projecting a very small increase in growth, too, from 8.6% last year to 8.9% at the midpoint of its revenue projection for 2026. The same is true at Merck, which is projecting a 1.9% increase after a 1.3% bump in 2025. It’s difficult to zero in on Sanofi’s 2026 expectations. Like many of its European counterparts, the French company favors a more general estimate, saying it expects sales to be up by a “high single-digit” margin versus the 6% growth it realized in 2025. Eli Lilly leads again in Q4Meanwhile, the song remained much the same at the top of the rankings as Eli Lilly continued its reign with by far the largest revenue growth in the fourth quarter at 43%, which was nearly triple that of second-place Daiichi Sankyo at 15%. It was the fifth straight quarter in which Lilly had the top growth rate in the industry among companies that generated at least $2 billion in the period. Lilly has racked up 11 straight quarters in which its revenue has increased by at least 20% year over year. During its five-quarter run with the highest increases, Lilly exceeded 40% growth in four of those quarters. The last time a company other than Lilly topped the rankings was in the third quarter of 2024, when Pfizer—boosted by a surprise spike in sales of its COVID products—achieved a 32% revenue gain. Lilly’s growth has been fueled by its diabetes and obesity drugs Mounjaro and Zepbound, which achieved combined sales of $36.5 billion in 2025 and were up considerably from $16.5 billion in 2024. There’s no sign of a slowdown in the momentum as the two tirzepatide products accounted for fourth-quarter sales of $11.7 billion, up from $10.1 billion in the previous quarter and 115% year over year. While 2025 overall was a remarkable year of growth for the company at 45%, Lilly is expecting the pace to subside, projecting that 2026 sales will come between $80 billion and $83 billion. At the midpoint, this would represent a year-over-year growth of 25%. One thing to keep in mind is that at this time last year, Lilly’s projected revenue window for 2025 was between $58 billion and $61 billion. The Indianapolis drugmaker ended up exceeding the estimate by a significant margin, generating sales of $65.1 billion. Lilly CEO David Ricks has repeatedly expressed his surprise at the unprecedented growth and the unique consumer dynamics in the obesity market.“The scale of this business and the way it’s been growing, the consumer part of it, along with the stocking dynamics, it’s just been a learning [experience] for us,” Ricks said in February of last year. “Our forecasters really nailed the rest of the portfolio. We don't have a problem with forecasting. It’s just—this market is quite different.” Slowdown in growth for Novartis, AZ, AmgenElsewhere, growth is slowing down for several other big companies in the industry.Novartis is not expecting (PDF) sales to decline in 2026 but is projecting a much smaller rate of growth, from an 8% rate in 2025 to a low single-digit increase this year. The beginning of the slowdown was apparent in the fourth quarter of last year when the company logged a sales increase of just 1%. That came after the Swiss company had posted revenue boosts of at least 8% in each of the previous nine quarters.The biggest factor in the slowdown is the loss of U.S. patent protection for Entresto, which dovetailed in July of last year with the launch of generic versions of the heart failure treatment. The pricing and competition effects were especially evident in the fourth quarter as Entresto sales fell by 45% from the same period in 2024.Amgen, which had a 10% growth rate in 2025, is projecting a 7% increase at the midpoint of its estimate as sales of three blockbusters are in decline. Bone drug Prolia reached peak sales of $4.4 billion last year. But the effect of biosimilar competition, which began last year, was apparent in quarterly results. In the first quarter, Prolia sales were up 10%, compared to the fourth quarter when they declined by 10%. Meanwhile, sales of Prolia’s sister med Xgeva fell 6% last year, and the company expects “accelerated sales erosion driven by increased competition, as multiple biosimilars have launched globally.” Sales of anti-inflammatory treatment Enbrel were already in decline in 2025, falling 33%, and should take another hit in 2026 thanks to the first wave of IRA price negotiations. After realizing a 9% increase in revenue in 2025, AstraZeneca is projecting (PDF) growth to be in the mid- to high single-digits. The company elaborated little on the forecast in its fourth-quarter presentation, though AZ is already grappling with declining sales for blockbuster Soliris, which lost its patent protection in the U.S. last year, and for Sanofi-partnered RSV antibody Beyfortus, as demand falls in the U.S.

BiosimilarAcquisitionFinancial Statement

11 Mar 2026

·allsci.com

BMS upbeat on protein degrader mezigdomide after Phase III results in relapsed multiple myeloma

Bristol Myers Squibb (BMS; NYSE: BMY) announced positive interim results from the SUCCESSOR-2 study, a Phase III trial evaluating oral mezigdomide in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma. The readout marks the first positive Phase III study for mezigdomide and the second for the company’s CELMoD program, a platform of next-generation cereblon-modulating protein degraders central to BMS’s hematology pipeline. SUCCESSOR-2 (NCT05552976) is a seamless Phase II/III, multicenter, randomized, open-label trial comparing mezigdomide plus carfilzomib and dexamethasone (MeziKd) against carfilzomib and dexamethasone alone (Kd) in patients with relapsed or refractory multiple myeloma previously exposed to anti-CD38 therapy and lenalidomide. The primary endpoint of the Phase III portion was progression-free survival. According to the company, MeziKd demonstrated a statistically significant and clinically meaningful improvement in PFS over Kd. Exact hazard ratios, median PFS values, and p-values were not disclosed in the topline release. Safety findings were consistent with the known profile of mezigdomide and the combination regimen, with no new signals reported. Key secondary endpoints — including overall survival, overall response rate, duration of response, MRD negativity, and health-related quality of life — will be reported at a future medical meeting. Patients continue to be followed for survival and safety. BMS stated that data will be shared with health authorities, with no specific NDA filing timeline disclosed. Cristian Massacesi, the company’s chief medical officer, said the results “reinforce the value of our CELMoD program and our targeted protein degradation platform” and “strengthen our confidence in bringing forward effective, accessible oral treatment options”. Mezigdomide is a cereblon E3 ligase modulator (CELMoD) designed to bind cereblon, a substrate receptor of the CRL4 E3 ubiquitin ligase complex, and redirect the complex to ubiquitinate and degrade the transcription factors Ikaros (IKZF1) and Aiolos (IKZF3). These proteins play key roles in the growth and survival of malignant plasma cells in multiple myeloma. By promoting their degradation, CELMoD agents enhance anti-tumor immune activity and induce myeloma cell death. The mechanism builds on the established immunomodulatory drug (IMiD) class, which includes lenalidomide and pomalidomide, therapies that have become central components of current multiple myeloma treatment regimens. Multiple myeloma remains an incurable malignancy characterized by repeated cycles of response and relapse. While treatment options for relapsed or refractory multiple myeloma (RRMM) have expanded substantially in recent years — including bispecific antibodies, CAR-T cell therapies, and antibody-drug conjugates — patients who have progressed on anti-CD38 antibodies and lenalidomide often face limited therapeutic options. In this setting, orally administered agents that can be combined with existing backbone regimens remain an important area of clinical development. The competitive landscape in RRMM spans several therapeutic modalities. Key competing assets include: Bristol Myers Squibb’s iberdomide, another CELMoD agent currently being evaluated in Phase III trials in combination with daratumumab and dexamethasone in relapsed or refractory multiple myeloma. Johnson & Johnson’s talquetamab, a bispecific antibody targeting GPRC5D and CD3 that is being evaluated in Phase III trials for relapsed disease. Pfizer’s elranatamab, a BCMA×CD3 bispecific antibody that received US FDA approval for relapsed or refractory multiple myeloma and is undergoing further Phase III evaluation. Johnson & Johnson and Legend Biotech’s BCMA-directed CAR-T therapy ciltacabtagene autoleucel, which the US FDA approved for multiple myeloma and is being studied in additional Phase III trials across earlier treatment lines. GSK’s BCMA-targeted antibody-drug conjugate belantamab mafodotin, which is being evaluated in ongoing Phase III combination studies following earlier regulatory setbacks. Mezigdomide’s oral administration and compatibility with established backbone regimens such as carfilzomib plus dexamethasone could position it as a convenient treatment option in later-line settings. However, the therapy’s eventual role in the treatment sequence will depend on the magnitude and durability of clinical benefit observed in Phase III studies relative to existing immunotherapies and cell-based approaches. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Phase 3Clinical ResultImmunotherapyCell TherapyDrug Approval

10 Mar 2026

·www.biospace.com

TECVAYLI®▼ (teclistamab) monotherapy application submitted to the EMA for relapsed/refractory multiple myeloma after at least one prior therapy

Application supported by Phase 3 data reinforcing teclistamab regimens as a potential standard of care after at least one prior therapy 1 Teclistamab monotherapy delivered superior progression-free survival and overall survival versus standard of care, reducing the risk of disease progression or death by 71% in a high unmet need patient population 2 BEERSE, BELGIUM, March 10, 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) as monotherapy for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy. Bringing new hope to a high unmet need population Despite major advances in frontline multiple myeloma treatment, including anti-CD38-based quadruplet regimens, most patients will ultimately relapse. 2 Outcomes are particularly poor once patients become refractory to key backbone therapies such as anti‑CD38 monoclonal antibodies and lenalidomide. 2,3 This patient population has historically faced limited choices and challenging second-line treatment pathways, reinforcing the need for additional effective immunotherapy options that can be given across practice settings. 3 “A significant number of patients with multiple myeloma continue to relapse and become refractory to currently available therapies, representing one of the largest and most challenging unmet needs in the disease,” said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “Making teclistamab monotherapy available to patients as early as second line, where it has the potential to meaningfully improve long-term outcomes and change the course of the disease, could bring new hope to patients and their families.” MajesTEC-9 study results The submission is supported by data from the Phase 3 MajesTEC-9 trial evaluating the efficacy and safety of teclistamab versus the standard of care of pomalidomide, bortezomib, and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in 614 patients with RRMM. 1 Results show teclistamab delivers superior progression-free survival (PFS) and overall survival (OS) versus standard of care as early as second line, including a 71% reduction in the risk of disease progression or death (hazard ratio [HR], 0.29; 95% confidence interval [CI], 0.23-0.38) and a 40% reduction in the risk of death (HR, 0.60; 95% CI, 0.43-0.83) in a patient population that was predominantly refractory to anti-CD38 monoclonal antibodies and lenalidomide. 2 The safety pro teclistamab monotherapy was clinically manageable and consistent with its known profile, with no new safety signals identified. 2 Infections can be managed with robust infection management protocols, which include patient monitoring, immunoglobulin therapy and antimicrobial prophylaxis. 4 The Independent Data Monitoring Committee recommended unblinding the study based on the strength of the data in the first pre-specified interim analysis. 2 This submission represents the first of several planned global regulatory filings, with full results to be presented at a future major medical meeting. “At Johnson & Johnson, we are driven by a clear purpose to deliver innovations that redefine expectations of what a multiple myeloma diagnosis means to patients, at every stage of the disease,” said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson. “With today’s regulatory milestone for teclistamab, we are advancing a widely available immunotherapy approach with the potential to support deep and sustained responses over time.” About the MajesTEC-9 study MajesTEC-9 (NCT05572515) is an ongoing, Phase 3 randomised study evaluating the safety and efficacy of teclistamab as a monotherapy versus pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with relapsed/refractory multiple myeloma (RRMM) who have received 1–3 prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide. 1 The majority of patients enrolled were refractory to anti-CD38 monoclonal antibodies (85%) and lenalidomide (79%) and more than 90% were refractory to their last line of therapy. 2 The primary endpoints are progression-free survival (PFS) and the number of participants reporting cytokine release syndrome (CRS) cases by severity. 1 Secondary endpoints include complete response or better (≥CR); duration of response (DOR); time to next treatment (TTNT); progression-free survival on next-line therapy (PFS2); overall survival (OS); number of participants with adverse events (AEs) and serious adverse events (SAEs) by severity; change from baseline in symptoms, functioning and overall health-related quality of life (HRQoL) as assessed by the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30); and time to worsening in symptoms, functioning and overall HRQoL. 1 The MajesTEC-9 study is a part of the MajesTEC clinical programme, which includes exploring the potential of teclistamab as a combination regimen. 1 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. 4,7 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. 4,8,9,10,11 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. 6 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. 12 ,13 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. 12,13 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. 14 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter. 15 ,16,17 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. 18 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. 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. END Key Search Terms MajesTEC-9 Phase 3 clinical trial TECVAYLI Teclistamab Teclistamab monotherapy 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 BCMA-targeted bispecific therapy EMEA haematology pipeline Multiple myeloma innovation Multiple myeloma treatment [1] ClinicalTrials.gov. A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-9). Available at: . Last accessed: March 2026. [2] Johnson & Johnson.com. TECVAYLI® monotherapy demonstrates superior progression-free and overall survival versus standard of care as early as first relapse in patients with multiple myeloma predominantly refractory to anti-CD38 therapy and lenalidomide. Available at: . Last accessed: March 2026. [3] Ramasamy K, et. al. Real-World Treatment Patterns and Clinical Outcomes in Patients With Multiple Myeloma Previously Treated With Lenalidomide and an Anti-CD38 Monoclonal Antibody. Clin Lymphoma Myeloma Leuk. 2025 May;25(5):337-348.e2. [4] European Medicines Agency. TECVAYLI Summary of Product Characteristics. Available at: . Last accessed: March 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: March 2026. [6] Johnson & Johnson.com. European Commission Approves Reduced Dosing Frequency for Janssen’s Bispecific Antibody TECVAYLI®▼ (teclistamab). Available at: . Last accessed: March 2026. [7] Moreau P, et al. Teclistamab in Relapsed or Refractory Multiple Myeloma. New England Journal of Medicine. 2022;287(6):494-505. [8] 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: March 2026. [9] ClinicalTrials.gov. A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (MajesTEC-2). Available at: . Last accessed: March 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: March 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: March 2026. [12] Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget. 2013;4(12):2186-2207. [13] American Society of Clinical Oncology. Multiple Myeloma: Introduction. Available at: . Last accessed: March 2026. [14] 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: March 2026. [15] 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. [16] 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. [17] Gavriatopoulou M, et al. Metabolic Disorders in Multiple Myeloma. Int J Mol Sci. 2021;22(21):11430. [18] American Cancer Society. Multiple Myeloma: Early Detection, Diagnosis and Staging. Available at: Last accessed: March 2026. CONTACT: Media contact: Jenni Mildon jmildon@its.jnj.com +44 7920 418 552 Investor contact: Jessica Margevich investor-relations@its.jnj.com

Phase 3Clinical ResultDrug ApprovalImmunotherapyASCO

100 Deals associated with Lenalidomide

External Link

KEGG	Wiki	ATC	Drug Bank
D04687	Lenalidomide	L04AX04	DB00480

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Large B-cell lymphoma	United States	Seagen, Inc.	11 Feb 2025
Marginal Zone B-Cell Lymphoma	United States	Bristol Myers Squibb Co.	28 May 2019
Adult T-Cell Leukemia-Lymphoma	Japan	Bristol-Myers Squibb KK	02 Mar 2017
Chromosome 5q Deletion Syndrome	European Union	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Chromosome 5q Deletion Syndrome	Iceland	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Chromosome 5q Deletion Syndrome	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Chromosome 5q Deletion Syndrome	Norway	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	European Union	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	Iceland	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	Norway	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	European Union	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	Iceland	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	Norway	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	European Union	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	Iceland	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	Norway	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Multiple Myeloma	United States	Bristol Myers Squibb Co.	29 Jun 2006

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
B-Cell Lymphoma	Phase 3	United States	AbbVie Deutschland GmbH & Co. KG	23 May 2024
B-Cell Lymphoma	Phase 3	China	AbbVie Deutschland GmbH & Co. KG	23 May 2024
B-Cell Lymphoma	Phase 3	Japan	AbbVie Deutschland GmbH & Co. KG	23 May 2024
B-Cell Lymphoma	Phase 3	Australia	AbbVie Deutschland GmbH & Co. KG	23 May 2024
B-Cell Lymphoma	Phase 3	Belgium	AbbVie Deutschland GmbH & Co. KG	23 May 2024
B-Cell Lymphoma	Phase 3	Brazil	AbbVie Deutschland GmbH & Co. KG	23 May 2024
B-Cell Lymphoma	Phase 3	Bulgaria	AbbVie Deutschland GmbH & Co. KG	23 May 2024
B-Cell Lymphoma	Phase 3	Canada	AbbVie Deutschland GmbH & Co. KG	23 May 2024
B-Cell Lymphoma	Phase 3	Croatia	AbbVie Deutschland GmbH & Co. KG	23 May 2024
B-Cell Lymphoma	Phase 3	Czechia	AbbVie Deutschland GmbH & Co. KG	23 May 2024

Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03477539 (CTgov)	Phase 2	Multiple Myeloma	49	Lenalidomide+Autologous Hematopoietic Stem Cell Transplantation+Daratumumab	ktrubrvmyo = mcofxsripd exumgziukl (ujvtbsigtk, gndjielzsm - srfcesuvna) View more	-	09 Mar 2026
NCT01919086 (CTgov)	Phase 2	Multiple Myeloma	30	Lenalidomide+Bortezomib+Dexamethasone	jotbdwpeui = ybinjkbvcs rkthbrxozr (xzcpgluvon, qkymafeggx - hxusybjsmj) View more	-	02 Mar 2026
Tandem Meetings ASTCT and CIBMTR2026	Not Applicable	Multiple Myeloma	140	Daratumumab+ bortezomib/cafilzomib+ lenalidomide+ dexamethasone (CD34+ cells <5×10^6/kg)	akxvrquxdj(phcaprisjs) = qypeqpeyvr sisqnkouhp (ntmejivype ) View more	Positive	04 Feb 2026
				Daratumumab+ bortezomib/cafilzomib+ lenalidomide+ dexamethasone (CD34+ cells ≥5×10^6/kg)	akxvrquxdj(phcaprisjs) = piexrtvifg sisqnkouhp (ntmejivype ) View more
Tandem Meetings ASTCT and CIBMTR2026	Not Applicable	Multiple Myeloma	71	Daratumumab+Bortezomib+Lenalidomide+Dexamethasone	kgahunhvty(wpmhxolusi) = wkytgtbifl sgyciuwhvx (catpgjjqxv ) View more	Positive	04 Feb 2026
				Daratumumab+Bortezomib+Lenalidomide+Dexamethasone (2025 IMS/IMWG high-risk criteria)	kgahunhvty(wpmhxolusi) = efjncfwkpu sgyciuwhvx (catpgjjqxv ) View more
Tandem Meetings ASTCT and CIBMTR2026	Not Applicable	Multiple Myeloma Consolidation \| Maintenance	179	CAR-T consolidation	pvzcurlrsh(wsnimsibbh) = jovxohknaz betxczwqus (aqitycapos ) View more	Negative	04 Feb 2026
				Lenalidomide maintenance	ycnmgvcdhr(bgjwvzmakf) = mkiwuzdvkt grmhjjhknc (dqoxflcpet ) View more
NCT02389517 (CTgov)	Phase 2	Multiple Myeloma \| Residual Neoplasm	42	Lenalidomide+Ixazomib Citrate+Dexamethasone (Arm I (Ixazomib Citrate, Lenalidomide, Dexamethasone))	ezxsxyvgst = jlrhptefaf dqlvextmju (mtxmeiuxcs, iyskdlxuxf - dpdsbufdax) View more	-	22 Jan 2026
				Lenalidomide (Arm II (Lenalidomide))	ezxsxyvgst = kyxpzazitb dqlvextmju (mtxmeiuxcs, jskkcfvyns - zcpkkvxbwc) View more
NCT05032820 (BMTCTN1902, CTgov)	Phase 2	Multiple Myeloma	40	leukapheresis+Lenalidomide+bb2121+Fludarabine+Cyclophosphamide	ufsxcsxuet = aizpyeshsl donlfmfvnt (fpmnnrrabn, ekpjcwmcbp - wpkwmylsaj) View more	-	12 Jan 2026
NCT03702725 (CTgov)	Phase 1	Relapse multiple myeloma \| Refractory Multiple Myeloma	14	Lenalidomide+Ibrutinib+Dexamethasone (Dose Level 1 (Starting DL))	bvmhocduko = wflfsnnugu esrcezklnp (kcbfdwgixq, lbnfqqxaim - yuilzcqhlg) View more	-	06 Jan 2026
				Lenalidomide+Ibrutinib+Dexamethasone (Dose Level 2)	bvmhocduko = apbauomqgl esrcezklnp (kcbfdwgixq, sungvwcohp - yndcrqdlmb) View more
NCT05409066 (EPCORE FL-1, Pubmed \| Lancet)	Phase 3	Refractory Follicular Lymphoma Second line	488	Epcoritamab + Lenalidomide + Rituximab	mmopphuvkq(njevwlwxbs) = kgsgpnyhwq rtkgpceywa (zqqelroqmi, 92 - 97) View more	Superior	01 Jan 2026
				Lenalidomide + Rituximab	mmopphuvkq(njevwlwxbs) = vsnymoomld rtkgpceywa (zqqelroqmi, 74 - 84) View more
NCT04270409 (ASH2025)	Phase 2	Smoldering Multiple Myeloma	36	Isatuximab+Lenalidomide	nizabsukgj(bfbzheaaeh) = jijfnxdxfy gmmbqjtsmu (amlnvvkozt ) View more	Positive	06 Dec 2025

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