An Open-Label, Non-Randomized, Phase II Study to Study the Efficacy of Talquetamab (JNJ-64407564) and Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma (OPTIMMAL)

Multiple myeloma (MM) is a heterogenous plasma cell malignancy characterized by clonal proliferation of plasma cells and organ damage. Autologous transplantation with high dose chemotherapy is the standard of care in frontline treatment of eligible patients with MM.

Start Date01 Nov 2025

Sponsor / Collaborator

Stanford University

[+1]

NCT06792825

/ Not yet recruitingPhase 2IIT

HM2023-43: A Phase 2 Trial of Tafasitamab in Combination With Lenalidomide+Rituximab in Treatment-naive Follicular Lymphoma and Marginal Zone Lymphoma

The study follows a Simon's two-stage phase II trial design to evaluate the safety and efficacy of tafasitamab added to rituximab and lenalidomide for two treatment-naïve, parallel, independent cohorts: follicular lymphoma (FL) and marginal zone lymphoma (MZ). Each cohort, FL and MZ, will be evaluated separately. This study is presented to the patient and consent is signed prior to the initiation of treatment for their primary malignancy.

Start Date01 Jul 2025

Sponsor / Collaborator

University of Minnesota Masonic Cancer Center

[+1]

NCT06892522

/ Not yet recruitingPhase 1

A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of Etentamig Monotherapy or Etentamig Combinations in Subjects With Multiple Myeloma

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine the safety, efficacy, and pharmacokinetics of Etentamig in adult participants with MM.
Etentamig is an investigational drug being developed for the treatment of MM. This study is broken into 4 substudies and each substudy consists of a dose escalation phase and dose expansion phase. Participants will receive escalating doses of etentamig alone or in combination with daratumumab and lenalidomide (DR), carfilzomib and dexamethasone (Kd) or lenalidomide (R). This will be followed by etentamig at the dose levels established during the escalation phases alone or in combination with DR, Kd, R. The participants can also receive daratumumab, lenalidomide and dexamethasone (DRd), R, or daratumumab, carfilzomib, and dexamethasone (DKd) as a comparator in the dose expansion phases. Around 440 adult participants with MM will be enrolled at approximately 50 sites worldwide
In all substudies, participants will receive escalating doses of etentamig as Intravenous (IV) infusions, alone or in combination with DR, R or Kd, followed by IV infusions of etentamig at the dose levels established during the escalation phases alone or in combination with IV and oral DRd, DKd, or R. The study duration is approximately 130 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Start Date02 Jun 2025

Sponsor / Collaborator

AbbVie, Inc.

100 Clinical Results associated with Lenalidomide

100 Translational Medicine associated with Lenalidomide

100 Patents (Medical) associated with Lenalidomide

9,207

Literatures (Medical) associated with Lenalidomide

31 Dec 2025·Hematology

Bortezomib, thalidomide, and dexamethasone versus bortezomib, lenalidomide, and dexamethasone in transplant-eligible newly diagnosed multiple myeloma: a systemic review and meta-analysis

Review

Author: Lin, Cheng-Hsien ; Teng, Chieh-Lin Jerry ; Su, Yu-Chen ; Wang, Yin-Che

BACKGROUND:

The current study aimed to compare treatment responses, the incidence of the need for auto-HSCT, and the occurrence of specific adverse events (AEs) between VTD and velcade, VRD induction regimens in patients with transplant-eligible newly diagnosed multiple myeloma (NDMM).

METHODS:

This systematic review and meta-analysis included 15 studies: six evaluating the VTD regimen and nine evaluating the VRD one. The primary endpoints were response rates after induction therapy and the incidence of a need for autologous hematopoietic stem cell transplantion (auto-HSCT) between the groups. We also examined the occurrence of grade 3 or 4 hematological, infection, and thrombotic AEs in both groups.

RESULTS:

The VTD group showed an overall response rate (ORR) of 93%, while the VRD group had an ORR of 86%. The very good partial response (VGPR) rates were 61% in the VTD group and 60% in the VRD one. The auto-HSCT rate was higher in the VTD group, averaging 93% compared to 70% in the VRD one. The incidence of grade 3 or 4 hematological AEs was 31% for VTD and 33% for VRD. The rates of grade 3 or 4 infection-related AEs were 9% in the VTD group and 14% in the VRD one. The incidence of grade 3 or 4 thrombotic AEs was 4% for VTD and 3% for VRD.

CONCLUSIONS:

With comparable safety profiles, VTD and VRD induction therapies are similarly effective for transplant-eligible NDMM, showing similar ORRs and VGPR rates.

01 Aug 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Simultaneous determination of thirteen related substances in lenalidomide API by a stability-indicating RP-HPLC method

Article

Author: Bi, Luye ; Zhang, Ling ; Sh, Dahua ; Yu, Yang ; Xu, Fan ; Cao, Zhiling ; Sun, Yuhan ; Huang, Maolong ; Xia, Siyi ; Yu, Xudong

The purpose of this study was to develop and validate a high performance liquid chromatography (HPLC) method for the separation and determination of related impurities and potential genotoxic impurity in the lenalidomide API. Chromatographic separation was performed on a Zorbax SB-AQ column (250 mm × 4.6 mm, 5 μm) at a wavelength of 220 nm using pH 4.0 phosphate buffer-acetonitrile as the mobile phase in gradient elution mode. The validation results demonstrate that the method has acceptable specificity, linearity, accuracy, precision and robustness. The detection limits and quantitation limits ranged from 2 to 17 ng/mL and from 6 to 50 ng/mL, respectively. A linear relationship was observed between the peak area and concentration of lenalidomide and impurities, with a correlation coefficient value of r ≥ 0.999. The formation and chemical structures of oxidation and base degradation products of lenalidomide have also been confirmed. The newly developed HPLC method is suitable for use in quality-control laboratories for qualitative and quantitative assessment of thirteen kinds of related substances in the lenalidomide API.

01 Jun 2025·International Journal of Pharmaceutics-X

Topical transdermal administration of lenalidomide nanosuspensions-based hydrogels against melanoma: In vitro and in vivo studies

Article

Author: Zhou, Menglu ; Jia, Haiyan ; Han, Zheyi ; Qiu, Haiying ; Lu, Hongjie ; Hou, Jingjing ; Yuan, Jingwei ; Ma, Yazhong ; Wu, Yan ; Zhang, Mengdi

Percutaneous neoadjuvant therapy has proven effective in diminishing tumor size and the surgical intervention area, which couldeffectively mitigate the risk of tumor recurrence and enhance immunotherapy efficacy. Lenalidomide, an approved medication orally used to treat myeloma, was loaded into nanosuspensions-based hydrogels (Len-NBHs) for transdermal administration as a percutaneous neoadjuvant therapy. This study was designed to investigate the inhibitory effect and mechanism of Len-NBHs on melanoma. Network pharmacology and transcriptomic analyses identified key targets and signaling pathways. The effects of lenalidomide on melanoma were further verified through Western blotting, immunohistochemistry, immunofluorescence, and quantitative real-time polymerase chain reaction，using both in vitro cell experiments and in vivo melanoma mouse models. Lenalidomide could induce melanoma cells apoptosis, disrupt cell cycle progression, impede cell migration and invasion, and modify tumor microenvironment (TME). Mechanistically, lenalidomide reversed the abnormal activation of the PI3K-AKT signaling pathway and the overexpression of CD93, while also recruiting CD8+ T cells, CD4+ T cells, and dendritic cells to infiltrate the tumor site. Transdermal administration of Len-NBHs represents a promising adjuvant therapy for the treatment of malignant melanoma. Preoperative administration of Len-NBHs can inhibit the outward spread of melanoma, reduce tumor size, thereby decreasing the surgical excision area and improving patient survival rates and prognosis.

864

News (Medical) associated with Lenalidomide

08 Apr 2025

·www.pharmaceutical-technology.com

EC approves extension of indication for Janssen-Cilag’s Darzalex

J&J has filed a supplemental biologics licence application with the US Food and Drug Administration for a new indication for daratumumab SC with VRd. Credit: josefkubes/Shutterstock. The European Commission (EC) has approved the extension of indication for Janssen-Cilag International’s Darzalex (daratumumab) subcutaneous (SC) formulation to be used in the frontline setting for treating newly diagnosed multiple myeloma (NDMM) in adults. Janssen-Cilag is a Johnson & Johnson (J&J) company. The approval allows for the use of daratumumab SC in conjunction with bortezomib, lenalidomide and dexamethasone (daratumumab-VRd). The therapy currently holds nine indications approved for multiple myeloma (MM) with five for frontline treatment, including regimens for patients both eligible and ineligible for autologous stem-cell transplant (ASCT). The latest approval follows October 2024’s indication extension for daratumumab-VRd to treat newly diagnosed patients eligible for ASCT, supported by the Phase III PERSEUS trial results. The trial focused on assessing the therapy’s SC-based quadruplet regimen for consolidation and induction therapy with daratumumab SC and lenalidomide maintenance. The trial assessed the safety and efficacy of daratumumab-VRd against VRd in NDMM subjects who were either transplant ineligible or for whom ASCT was not intended as initial treatment. Daratumumab-VRd’s overall safety profile was consistent with the known profiles of daratumumab SC and VRd. Johnson & Johnson innovative medicine EMEA therapeutic area haematology lead Edmond Chan stated: “Daratumumab has become a cornerstone of multiple myeloma treatment over the past decade and is now the only anti-cluster of differentiation 38 (CD38) antibody approved to treat all patient types in the frontline setting, regardless of transplant eligibility. “This latest approval confirms the enhanced benefit of daratumumab SC-based quadruplet regimens and its versatility and effectiveness in addressing the diverse needs of those affected by this complex disease.” J&J also filed a supplemental biologics licence application with the US Food and Drug Administration in September 2024 for a new indication for daratumumab SC with VRd to treat adults with NDMM who are either ineligible for ASCT or for whom ASCT is deferred. In 2024, the company announced the submission of a type II variation application to the European Medicines Agency (EMA) for its Darzalex-based quadruplet therapy for MM. In 2012, J&J’s Janssen Biotech and Genmab entered a global agreement granting J&J exclusive development, manufacturing and commercialisation rights for daratumumab.

Phase 3Drug ApprovalLicense out/inClinical ResultAccelerated Approval

07 Apr 2025

·pipelinereview.com

European Commission approves Johnson & Johnson’s subcutaneous DARZALEX® (daratumumab)-based quadruplet regimen for the treatment of patients with newly diagnosed multiple myeloma, regardless of transplant eligibility

Approval cements daratumumab as a foundational therapy in newly diagnosed multiple myeloma and the only anti-CD38 antibody for all patient types in this setting Phase 3 CEPHEUS study shows significant improvement in minimal residual disease (MRD)-negativity rate, progression-free survival and complete response or better versus standard of care 1 BEERSE, Belgium I April 07, 2025 I Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the European Commission (EC) has approved an indication extension of DARZALEX ® (daratumumab) subcutaneous (SC) formulation in the frontline setting. The approval is for daratumumab SC in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM). 1 “Multiple myeloma is a complex and evolving disease. Starting with more effective regimens in the frontline setting offers patients the best chance of sustained long-term outcomes by preventing disease resistance and relapse,” said Professor Katja Weisel, University Medical Centre Hamburg-Eppendorf. “The subcutaneous daratumumab-VRd regimen delivers an effective and convenient new standard of care for patients with newly diagnosed multiple myeloma, regardless of transplant eligibility, with responses that are deep and durable, and translate into significantly reduced risk of disease progression or death.” Daratumumab is now approved in nine indications for multiple myeloma, five of which are in the frontline setting, including as part of treatment regimens for newly diagnosed patients who are eligible or ineligible for autologous stem-cell transplant (ASCT). 1 Today’s approval follows the indication extension approval for daratumumab-VRd in October 2024, for the treatment of newly diagnosed patients with multiple myeloma who are eligible for ASCT, based on the results from the Phase 3 PERSEUS study. The study evaluated this daratumumab SC-based quadruplet regimen for induction and consolidation therapy, followed by daratumumab SC and lenalidomide maintenance. 2,3 “Daratumumab has become a cornerstone of multiple myeloma treatment over the past decade and is now the only anti-CD38 antibody approved to treat all patient types in the frontline setting, regardless of transplant eligibility,” said Edmond Chan, MBChB, M.D. (Res), EMEA Therapeutic Area Lead Haematology, Johnson & Johnson Innovative Medicine. “This latest approval confirms the enhanced benefit of daratumumab SC-based quadruplet regimens and its versatility and effectiveness in addressing the diverse needs of those affected by this complex disease.” The Phase 3 CEPHEUS (NCT03652064) study evaluated the efficacy and safety of daratumumab-VRd (n=197) compared to VRd (n=198) for patients with NDMM who are transplant ineligible or for whom ASCT was not planned as initial therapy (transplant ineligible or deferred). 1 Data from the study were previously presented at the 2024 International Myeloma Society (IMS) Annual Meeting. 4 At a median follow-up of 59 months, the primary endpoint was met, with an overall minimal residual disease (MRD)-negativity rate at a sensitivity of 10 -5 (no cancer cells detected within 100,000 bone marrow cells) of 60.9 percent for patients receiving daratumumab-VRd and 39.4 percent for VRd (Odds ratio [OR], 2.37; 95 percent confidence interval [CI], 1.58-3.55; p <0.0001). 1 Similarly, the proportion of patients achieving sustained MRD-negativity of ≥ 12 months almost doubled with daratumumab-VRd vs VRd (48.7 percent vs 26.3 percent; OR, 2.63; 95 percent CI, 1.73-4.00; p <0.0001). 1 The daratumumab SC-based quadruplet regimen, compared to VRd, also significantly increased the depth of response with higher rates of complete response (CR) or better. 1 The CR or better rate was 81.2 percent with daratumumab-VRd vs 61.6 percent with VRd (OR 2.73; 95 percent CI, 1.71-4.34; p <0.0001). 1 The study also demonstrated that daratumumab-VRd significantly reduced the risk of progression or death by 43 percent (Hazard ratio [HR], 0.57; 95 percent CI, 0.41-0.79; p <0.0005) vs VRd. The median progression-free survival was not reached for daratumumab-VRd vs 52.6 months for VRd. 1 Overall survival data were not yet mature. The overall safety profile of daratumumab-VRd was consistent with the known safety profiles for daratumumab SC and VRd. 4 The most common (>10 percent) Grade 3/4 haematologic and non-haematologic adverse events with daratumumab-VRd vs VRd were neutropenia (44.2 percent vs 29.7 percent), thrombocytopenia (28.4 percent vs 20.0 percent), anaemia (13.2 percent vs 11.8 percent), peripheral neuropathies (8.1 percent vs 8.2 percent), diarrhoea (12.2 percent vs 9.2 percent), and COVID-19 (11.2 percent vs 4.6 percent). 4 “At Johnson & Johnson, our dedication to advance multiple myeloma research spans more than 20 years and our commitment to transforming outcomes for patients has never been stronger than it is today,” said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine. “This landmark approval enables us to offer all patient populations access regardless of age, fitness or risk to a daratumumab-based triplet or quadruplet regimen in the frontline setting – a critical step towards our ultimate goal of delivering a functional cure.” Johnson & Johnson also submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration seeking approval of a new indication for daratumumab SC in combination with VRd for the treatment of adult patients with NDMM for whom ASCT is deferred or who are ineligible for ASCT, on 30 September 2024. About the CEPHEUS Study CEPHEUS ( NCT03652064 ) is an international, randomised, open-label, Phase 3 study comparing subcutaneous daratumumab, bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) with standard bortezomib, lenalidomide, and dexamethasone (VRd). 4,5 The trial enrolled 395 patients with newly diagnosed multiple myeloma who were either ineligible for stem cell transplantation (SCT) or for whom SCT is not planned. 4 The primary endpoint was overall minimal residual disease (MRD)-negativity rate. 4 The minimum age for participation was 18 years for patients in both the daratumumab-VRd arm and VRd arm, with a median patient age of 70 (range 31-80). 4 The study was conducted in 13 countries across North America, South America, and Europe. 4 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. 6 Daratumumab is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma. 7 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE ® drug delivery technology. 7 CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease. 7 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death. 7 Daratumumab may also have an effect on normal cells. 7 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival. 4,8,9,10,11,12,13,14,15 For further information on daratumumab, please see the Summary of Product Characteristics at: https://ec.europa.eu/health/documents/community-register/html/h1101.htm . 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. 16,17 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. 17 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. 18 People living with multiple myeloma experience relapses which become more frequent with each line of therapy 19,20 while remissions become progressively shorter. 19,20,21 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. 22 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 www.innovativemedicine.jnj.com/emea . Follow us at www.linkedin.com/company/jnj-innovative-medicine-emea . Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc., and Janssen Research & Development, LLC are Johnson & Johnson companies. 1 European Medicines Agency. DARZALEX (daratumumab) Summary of Product Characteristics. April 2025. 2 Rodríguez-Otero P, et al. Daratumumab (DARA) + bortezomib/lenalidomide/dexamethasone (VRd) in transplant-eligible (TE) patients (pts) with newly diagnosed multiple myeloma (NDMM): Analysis of minimal residual disease (MRD) in the PERSEUS trial. 2024 American Society for Clinical Oncology Annual Meeting. June 3, 2024. 3 Johnson & Johnson Innovative Medicine EMEA. DARZALEX® (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible. Available at: https://www.jnj.com/media-center/press-releases/darzalex-daratumumab-sc-based-quadruplet-regimen-approved-by-the-european-commission-for-patients-with-newly-diagnosed-multiple-myeloma-who-are-transplant-eligible . Last accessed: April 2025. 4 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. 21st International Myeloma Society (IMS) Annual Meeting. September 25 – 28, 2024. 5 Clinicaltrials.gov. A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy. NCT03652064. Available at: https://clinicaltrials.gov/study/NCT03652064?term=NCT03652064&cond=Multiple%20Myeloma&rank=1&a=63 . Last accessed: April 2025. 6 Johnson & Johnson [data on file]. RF-452129. Number of patients treated with DARZALEX worldwide as of December 2024. 7 Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX ® (Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications. Available at: http://www.businesswire.com/news/home/20200604005487/en/European-Commission-GrantsMarketingAuthorisation-for-DARZALEX%C2%AE%E2%96%BC-daratumumab-SubcutaneousFormulation-for-all-CurrentlyApproved-Daratumumab-Intravenous-Formulation-Indications . Last accessed: April 2025. 8 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, openlabel, phase 3 study. Lancet 2019;394(10192):29-38. 9 Facon T, et al. MAIA Trial Investigators. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Engl J Med 2019;380(22):2104-2115. 10 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:P132-141. 11 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. 12 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. 13 Chari A, et al. Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. Blood 2017;130(8):974-981. 14 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. 15 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. 16 Abdi J, et al. Drug resistance in multiple myeloma: latest findings on molecular mechanisms. Oncotarget 2013;4(12):2186-2207. 17 American Society of Clinical Oncology. Multiple myeloma: introduction. Available at: https://www.cancer.org/cancer/types/multiple-myeloma/if-you-have-multiple-myeloma . Last accessed: April 2025. 18 ECIS – European Cancer Information System. Estimates of cancer incidence and mortality in 2022, by country. Multiple myeloma. Available at: https://ecis.jrc.ec.europa.eu/explorer.php?$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: April 2025. 19 Bhatt P, Kloock C, Comenzo R. Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse. Curr Oncol. 2023;30(2):2322-2347. 20 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. 21 Gavriatopoulou M, et al. Metabolic Disorders in Multiple Myeloma. Int J Mol Sci. 2021;22(21):11430. 22 American Cancer Society. Multiple myeloma: early detection, diagnosis and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf . Last accessed: April 2025. SOURCE: Johnson & Johnson

Clinical ResultPhase 3Drug ApprovalASCOLicense out/in

02 Apr 2025

·www.echemi.com

2024 Top 10 Oncology Products Set New Sales Records

In 2024, the oncology drug market continues to hold a pivotal position within the global pharmaceutical industry, achieving record-breaking sales that reflect unprecedented growth potential. With advancements in precision medicine and immuno-oncology, innovative therapies such as targeted treatments and immune checkpoint inhibitors have seen remarkable commercial success worldwide. The leading cancer drugs are not only increasing in sales but are also driving technological innovation in cancer treatment, significantly benefiting numerous patients. By analyzing the top ten oncology products based on sales in 2024, we can explore how these drugs are shaping the future of cancer therapy and their importance to pharmaceutical companies and the healthcare system as a whole. Keytruda (pembrolizumab) Developer: Merck Modality: Monoclonal Antibody Mechanism: PD-1 Inhibitor Launch Date: September 14, 2014 Indications: Melanoma, metastatic non-small cell lung cancer, and several others Sales in 2024: $29.48 billion (18% increase) Market Analysis: Keytruda continues to dominate the market with expanding indications. Its patent is set to expire in 2028, with peak sales expected by 2027. Darzalex (daratumumab) Developer: Johnson & Johnson / Genmab Modality: Monoclonal Antibody Mechanism: Anti-CD38 Antibody Launch Date: November 16, 2015 Indications: Multiple Myeloma Sales in 2024: $11.67 billion (20% increase) Market Analysis: Darzalex significantly improves survival rates in multiple myeloma patients, maintaining strong growth momentum. Opdivo Developer: Bristol-Myers Squibb Modality: Monoclonal Antibody Mechanism: PD-1 Inhibitor Launch Date: December 22, 2014 Indications: Melanoma, lung cancer, and others Sales in 2024: $9.304 billion (7% increase) Market Analysis: Opdivo is actively pursuing additional opportunities, including new trials for various cancers. Tagrisso (osimertinib) Developer: AstraZeneca Modality: Small Molecule Mechanism: EGFR Tyrosine Kinase Inhibitor Launch Date: November 13, 2015 Indications: Non-small cell lung cancer Sales in 2024: $6.58 billion (12% increase) Market Analysis: Tagrisso shows significant clinical efficacy for EGFR-mutated non-small cell lung cancer. Imbruvica (ibrutinib) Developer: Johnson & Johnson / AbbVie Modality: Small Molecule Mechanism: BTK Inhibitor Launch Date: November 13, 2013 Indications: Chronic Lymphocytic Leukemia Sales in 2024: $3.347 billion (6.9% decrease) Market Analysis: Despite a drop in sales, Imbruvica remains a crucial asset for AbbVie. Xtandi (enzalutamide) Developer: Pfizer / Astellas Modality: Small Molecule Mechanism: Androgen Receptor Inhibitor Launch Date: August 31, 2012 Indications: Prostate Cancer Sales in 2024: $2.04 billion (23% increase) Market Analysis: Xtandi continues to gain traction in various stages of prostate cancer treatment. Revlimid (lenalidomide) Developer: Bristol-Myers Squibb Modality: Small Molecule Mechanism: Immunomodulator Launch Date: December 27, 2005 Indications: Multiple Myeloma Sales in 2024: $5.773 billion (5% decrease) Market Analysis: Revlimid’s market share has been impacted by generic competition after patent expiration. Verzenio (abemaciclib) Developer: Eli Lilly Modality: Small Molecule Mechanism: CDK4/6 Inhibitor Launch Date: September 28, 2017 Indications: Breast Cancer Sales in 2024: $5.307 billion (37% increase) Market Analysis: Verzenio effectively inhibits tumor cell proliferation, showing remarkable efficacy in HR+ HER2- breast cancer. Lynparza (olaparib) Developer: AstraZeneca / Merck Modality: Small Molecule Mechanism: PARP Inhibitor Launch Date: December 19, 2014 Indications: Ovarian Cancer Sales in 2024: $3.672 billion (7% increase for AstraZeneca) Market Analysis: Lynparza continues to expand its indications, providing a significant market opportunity. Imfinzi (durvalumab) Developer: AstraZeneca Modality: Monoclonal Antibody Mechanism: PD-L1 Inhibitor Launch Date: May 1, 2017 Indications: Lung Cancer Sales in 2024: $4.717 billion (9% increase) Market Analysis: Imfinzi is gaining traction due to its expanding range of approved indications. While small molecules have a slight advantage in numbers among the top ten products, the leading three are monoclonal antibodies, with sales figures nearing or exceeding $10 billion. In total, small molecules achieved sales of $35.1 billion, while monoclonal antibodies reached $55.2 billion. From an indication perspective, most of the top ten products target solid tumors (seven), while three focus on blood cancers, highlighting significant unmet needs and development potential in the hematologic oncology market. The future may see more cell and gene therapies entering this field, playing an increasingly important role.

Drug ApprovalImmunotherapyGene Therapy

100 Deals associated with Lenalidomide

External Link

KEGG	Wiki	ATC	Drug Bank
D04687	Lenalidomide	L04AX04	DB00480

R&D Status

Approved

10 top approved records.

to view more data

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
Plasmacytoma	Phase 3	United States	Millennium Pharmaceuticals, Inc.	01 Dec 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	United States	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	China	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	Japan	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	Australia	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	Belgium	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	Canada	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	Czechia	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	France	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	Ireland	Celgene Corp.	17 Feb 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05564052 (VEGA, CTgov)	Phase 2	Mantle cell lymphoma refractory	36	Ibrutinib+Rituximab (Arm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2)	yjwkneuled = iletrpsfvf nohwuhnaal (fpyvidpokt, hpcsyqiqhf - qeevjjsbch) View more	-	25 Mar 2025
				Ibrutinib+Rituximab (Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2)	yjwkneuled = muqjnzlhsa nohwuhnaal (fpyvidpokt, qovuudzllc - paewztbdla) View more
NCT02916771 (###DELETE \| NCT02916771, CTgov)	Phase 2	Smoldering Multiple Myeloma	55	Lenalidomide+Ixazomib+Dexamethasone	fhrnomjktr = frazqgqjgt laittgibvw (hxttmzebpr, igolbtbsyc - mdendbhscb) View more	-	05 Mar 2025
NCT04113018 (MRD-driven phase 2 study, Pubmed \| Blood Adv)	Phase 2	Multiple Myeloma next-generation sequencing-based MRD	39	Daratumumab, Carfilzomib, Lenalidomide, Dexamethasone	wiubzgqfhb(vxtlpieoxb) = ctujehdkuq qrmwjckolh (eavvllxryb, 10^ - 5)	Positive	11 Feb 2025
NCT01718743 (CTgov)	Phase 2	Multiple Myeloma \| Hematopoietic stem cell transplantation	64	Questionnaire Administration+Lenalidomide+Ixazomib Citrate	xphagshjuo(lctvfgxdzi) = jzscnihche qwzaexfckg (lmqxpfoqzg, qkvahyroyg - acxfaxpbld) View more	-	28 Jan 2025
NCT04680052 (inMIND, ASH2024) Manual	Phase 3	Follicular Lymphoma	548	Tafasitamab + Lenalidomide + Rituximab	pnmmsgeqdq(pqkfubgakz) = ejwcgvwyba orekxrlskf (doydilhwfn ) View more	Positive	10 Dec 2024
				Placebo + Lenalidomide + Rituximab	pnmmsgeqdq(pqkfubgakz) = fpiuafuknb orekxrlskf (doydilhwfn ) View more
ASH2024 Manual	Not Applicable	Multiple Myeloma First line	193	Ixazomib,LenalidomideeDexamethasonehasone (IRd)	cafclfpcly(vbifrtvlwd) = wtshzjjdqy kadbbcacvf (jxgypdpkkt, 11.2) View more	Positive	09 Dec 2024
				Bortezomib,LenalidomideeDexamethasonehasone (VRd)	cafclfpcly(vbifrtvlwd) = aelhuvjsrs kadbbcacvf (jxgypdpkkt, 3.9) View more
NCT03319667 (IMROZ, ASH2024) Manual	Phase 3	Multiple Myeloma First line	446	Isatuximab, Bortezomib, Lenalidomide, and Dexamethasone (Isa-VRd)	kbhzzngzog(qmjyksechk) = elsldxzpsv ipepdvpzol (aynigwgfky ) View more	Positive	09 Dec 2024
				Bortezomib, Lenalidomide, and Dexamethasone (VRd)	kbhzzngzog(qmjyksechk) = iwxklgczxl ipepdvpzol (aynigwgfky ) View more
NCT03223610 (ASH2024) Manual	Phase 1/2	Mantle-Cell Lymphoma	36	Venetoclax 2IbrutinibPrednisoneObinutuzumabLenalidomide	creldemevk(xxwzkenwfd) = thrombocytopenia (14%), neutropenia (13%), and anemia (10%) acceikinqj (popchlnvzf ) View more	Positive	09 Dec 2024
				Venetoclax 4IbrutinibPrednisoneObinutuzumabLenalidomide
ASH2024 Manual	Phase 1	Diffuse Large B-Cell Lymphoma	22	Polatuzumab Vedotin+Zanubrutinib+Rituximab+Lenalidomide	jtkuutkbpe(qjuesozftm) = pabckflrbb bsdftiyaqm (exaekvziid ) View more	Positive	09 Dec 2024
ASH2024	Not Applicable	Recurrent Multiple Myeloma	-	Belantamab mafodotin 1.4 mg/kg	uhcfwqlerv(djtqntuakv) = 89.5% experienced blurred vision nsjdzdaiqc (lmxuqdfusp ) View more	-	09 Dec 2024
				Belantamab mafodotin 1.9 mg/kg

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