At the end of each month, the International Myeloma Foundation (IMF) brings you the latest and most relevant news (myeloma research, clinical trials, treatments, drug authorizations, and more) to give a renewed sense of hope, courage, and resilience to the myeloma community. Through these encouraging developments that bring us closer to a cure, the IMF’s vision is slowly but surely coming to fruition: A world where every myeloma patient can live life to the fullest, unburdened by the disease. 
 
 

Research 
 

Bridging intensity is associated with impaired hematopoietic recovery following BCMA CAR T for MM — Blood Advances (April 2025) 
 

What is the purpose of the study? 
For patients with relapsed or refractory multiple myeloma, CAR T-cell therapy has become a vital and significant form of treatment. However, because it takes time to prepare CAR T cells (usually weeks), patients often need other treatment—called "bridging therapy"—to control their disease while they wait. 
 
This study looked at how different types of bridging therapy affect blood cell recovery after CAR T treatment in 158 patients. Researchers grouped the bridging therapies by how intense they were: no chemotherapy (non-CTX), moderate chemotherapy (1–2 drugs), or intensive chemotherapy (3 or more drugs or high-dose therapy with a stem cell transplant). 
 
Why this study matters 
Researchers discovered that the more intense the chemotherapy, the harder it was for patients' blood counts to recover after CAR T therapy. Patients who received intensive chemotherapy had slower recovery of neutrophils and platelets, more infections, and a higher chance of low blood counts (called cytopenias) later on. 
 
The study suggests that less intense or targeted treatments may be better for bridging in some patients. It also highlights the need for extra care and monitoring for those who receive stronger chemotherapy before their CAR T-cell infusion. 
 
 
Reference: 
Jan Hendrik Frenking, Xiang Zhou, et.al. Bridging intensity is associated with impaired hematopoietic recovery following BCMA CAR-T therapy for multiple myeloma. Blood Adv 2025; bloodadvances.2024015732. doi: https://doi.org/10.1182/bloodadvances.2024015732   (https://ashpublications.org/bloodadvances/article/doi/10.1182/bloodadvances.2024015732/536987/Bridging-intensity-is-associated-with-impaired)
 
 

Revised free light chain reference intervals enhance risk stratification in MGUS and reduce overdiagnosis — Blood Cancer Journal (April 2025) 
 

(Note: A correction was made to the study on May 27, 2025: Blood Cancer Journal https://doi.org/10.1038/s41408-025-01289-7 (https://www.nature.com/articles/s41408-025-01289-7), published online 28 Apr 2025) 
 
What is the purpose of this study? 
Doctors use a lab test called the free light chain (FLC) ratio to help estimate a person’s risk of developing multiple myeloma from monoclonal gammopathy of undetermined significance (MGUS). Recently, researchers created new FLC reference ranges that take into account a person’s age and kidney function.  

Using the updated reference ranges, 16% of individuals with MGUS were moved from a higher-risk group to a low-risk group. This shows the new reference ranges work well, helping doctors better predict which patients are actually at risk of disease progression and reclassify those who were previously labeled as high risk to low risk. 

Why this study matters 
In this study of nearly 7,000 people with MGUS: 

• About 1 in 3 people who were previously told they had an abnormal FLC ratio were reclassified as normal using the new guidelines. 
• People in this reclassified group had no higher risk of developing myeloma than those who always had normal results. 
• People still classified as abnormal with the new ranges did have a higher risk of progression. 

Because of these new guidelines, doctors can more accurately tell who are truly at risk—and avoid giving unnecessary treatments to those who are low risk. 

Reference: 
Maeng, C.V., Rögnvaldsson, S., Einarsson Long, T. et al. Revised free light chain reference intervals enhance risk stratification in monoclonal gammopathy of undetermined significance and reduce overdiagnosis. Blood Cancer J. 15, 80 (2025). https://doi.org/10.1038/s41408-025-01289-7   (https://www.nature.com/articles/s41408-025-01289-7 ) 
 

Universal driving restrictions beyond 4 weeks appear unnecessary following CAR T therapy in MM — Blood Advances (May 2025) 

 

What is the purpose of this study? 
CAR-T therapies like ide-cel and cilta-cel have greatly improved outcomes for patients with relapsed/refractory multiple myeloma. However, current FDA and EMA guidelines recommend that patients avoid driving for 8 weeks after infusion due to concerns about neurotoxicity.  
  

1. To examine whether 8-week driving restrictions are truly needed for MM patients receiving CAR-T therapy. 
2. To use real-world patient data and physician surveys to assess the actual risk of driving-related adverse events (drAEs). 

This study reviewed real-world data from 586 patients and found that driving-related adverse events (drAEs) after week 4 were extremely rare (only 1% of patients). A physician survey also showed most experts disagreed with the need for driving restrictions beyond the first month. 

Limitations of the study 

• Underreporting events is possible. 
• No patient surveys were included (to avoid asking about non-compliance). 
• No formal driving assessments (neurological or vision testing). 
• FDA seizure reports exist but lack context and do not confirm link to MM CAR-T. 

 

Results and Recommendations 

• Only 1% of patients had any new driving-related issues after week 4. 
• Driving risks are very low after the first month. 
• Recommend updating FDA and EMA guidelines: 
• Keep 4-week driving restrictions. 
• Allow individualized decisions after week 4 based on symptoms and expert evaluation. 
• This change would be evidence-based and better reflect patient needs. 

 

Why this study matters 
The study concludes that extending driving restrictions to 8 weeks may be unnecessary for most patients and suggests updating the guidelines to allow case-by-case decisions after week 4. 

Reference: 
Rahul Banerjee, Alicia Richards, et al. Universal driving restrictions beyond 4 weeks appear unnecessary following CAR-T therapy in multiple myeloma. Blood Adv 2025; 9 (9): 2336–2340. doi: https://doi.org/10.1182/bloodadvances.2025016131 (https://ashpublications.org/bloodadvances/article/9/9/2336/536086/Universal-driving-restrictions-beyond-4-weeks ) 
 

Comparative Efficacy of Ciltacabtagene Autoleucel Versus Standard-of-Care Treatments for Patients with Previously Treated RRMM: A Matching-Adjusted Indirect Comparison — Advances in Therapy (May 2025) 
 

 
What is the purpose of this study? 
This study compared the effectiveness of the CAR-T therapy cilta-cel to four other treatments (EloPd, IsaKd, IsaPd, and SVd) for people with relapsed or refractory multiple myeloma (RRMM) who had already tried at least one treatment and no longer responded to lenalidomide. 
 
Using a method called matching adjusted indirect comparisons (MAICs), researchers adjusted cilta-cel patient data to match patients in the other trials. They then compared outcomes like response rates, how long patients lived without disease progression (PFS), and overall survival (OS). 
 
What the results revealed 
Results showed that cilta-cel: 

• Had better response rates than all other treatments. 
• Led to a higher number of patients achieving deep responses (VGPR or CR). 
• Reduced the risk of disease progression or death by up to 69%. 
• Improved overall survival compared to EloPd, IsaPd, and SVd. 

 
Why this study matters 
Cilta-cel showed clear advantages in both response and survival outcomes, making it a stronger treatment option for RRMM patients who no longer respond to lenalidomide.

 
Reference: 
Puig, N., Diels, J., van Sanden, S. et al. Comparative Efficacy of Ciltacabtagene Autoleucel Versus Standard-of-Care Treatments for Patients with Previously Treated Relapsed or Refractory Multiple Myeloma: A Matching-Adjusted Indirect Comparison. Adv Ther (2025). https://doi.org/10.1007/s12325-025-03205-8  (https://link.springer.com/article/10.1007/s12325-025-03205-8)
 
 

Extramedullary Myeloma is Genomically Complex and Characterized by Near-Universal MAPK Pathway Alterations — Blood Advances (May 2025) 
 
 

What is the purpose of this study? 

1. Extramedullary multiple myeloma (EMD) almost always involves changes in the MAPK pathway, a key signaling system in cells. 
2. EMD is genetically more complex than regular multiple myeloma, with more mutations, frequent 1q gain/amplification, and changes in the MAX gene. 

EMD is a more aggressive form of multiple myeloma that doesn't respond as well to standard treatments. To better understand what causes it, researchers studied tumor samples from patients with EMD using whole exome sequencing (WES).  
 
 
What the findings revealed 

• 94% of EMD tumors had mutations in the MAPK pathway (compared to 60% in bone marrow samples). 
• Common mutated genes include NRAS, KRAS, and BRAF, which help drive the disease. 
• Additional mutations were found in genes related to cell movement, adhesion, and epigenetic regulation, though most of these were not dominant. 
• There were also frequent mutations in tumor suppressor genes like MAX and CDKN2C. 
• EMD tumors had a higher number of genetic changes overall, showing greater genomic complexity than tumors in the bone marrow. 

 
Why this study matters 
Overall, this study shows that EMD is a genetically unique and complicated form of myeloma and targeting these specific mutations could help develop better treatments. 
 
 
Reference: 
Saurabh Zanwar, Joseph Novak,  et al. Extramedullary Myeloma is Genomically Complex and Characterized by Near-Universal MAPK Pathway Alterations. Blood Adv 2025; bloodadvances.2025016619. doi: https://doi.org/10.1182/bloodadvances.2025016619 (https://ashpublications.org/bloodadvances/article/doi/10.1182/bloodadvances.2025016619/537300/Extramedullary-Myeloma-is-Genomically-Complex-and) 
 

Genomic landscape of MM and its precursor conditions — Nature Genetics (May 2025) 

 

What is the purpose of this study? 
This study aims to find better ways to identify which patients with early signs of multiple myeloma are most at risk of developing the full disease. Researchers looked at genetic data from over 1,000 patients, including some with early (precursor) stages of the disease. They discovered key genetic changes and used them to create a simple scoring system called the "MM-like" score, which shows how close a patient might be to developing active multiple myeloma. This research helps us understand when and how the disease starts and changes over time.  
  
 

What findings revealed 

1. The team found both well-known and new genetic mutations—some in coding regions (which affect proteins) and others in non-coding regions (which regulate how genes work)—that show early in MM's development. 
2. They created an "MM-like genomic score" using 17 key genetic changes. This score helps doctors tell which patients are more likely to get worse and who might stay stable. It works with different types of genetic testing and can be used in both research and clinical settings. 
3. Myeloma progresses step by step and builds through a "ladder climbing" process, where certain mutations appear later and push the disease further toward cancer. 
4. The first genetic changes may start as early as a person’s 20s or 30s, even though most people aren’t diagnosed until much later. By the time doctors detect MGUS or SMM, the cancer might already be 20–30 years old. 
5. Instead of repeated bone marrow biopsies, doctors might be able to use less invasive testing options to track cancer through cell-free DNA or tumor cells in the bloodstream. 
6. Some patients with MGUS or SMM might actually already have myeloma based on their genetics, even with no symptoms. More studies are being done to see if treating these patients earlier would help. 
7. Mutations in non-coding DNA and changes in how genes are turned on/off (epigenetics) might also play a big role in pushing the disease forward. 
8. Eventually, full genome sequencing might replace older methods and allow doctors to better predict which patients are at high risk and should be treated sooner. 

  
 
Why this study has potential 
This study looked at how early stages of myeloma (MGUS and SMM) slowly change into full-blown myeloma. Using advanced genetic testing on a large group of untreated patients, the researchers discovered that many important cancer-related genetic changes are already present in these early stages. 
 
The study gives a clearer picture of how multiple myeloma develops from early stages. It introduces a new genetic score to help doctors predict who’s at risk and suggests better, less invasive ways to monitor the disease over time. Overall, the study shows how genetic testing can potentially help doctors better track and predict the disease's progress.* 
 
* Please note that this is only a summary of the research abstract; it is not a definitive source of medical advice.   
 
Reference: 
Alberge, JB., Dutta, A.K., Poletti, A. et al. Genomic landscape of multiple myeloma and its precursor conditions. Nat Genet (2025). https://doi.org/10.1038/s41588-025-02196-0  (https://www.nature.com/articles/s41588-025-02196-0)
 

Health Equity 

 
The benefits of telehealth in promoting equity in blood cancer care — results of a multi-stakeholder forum and narrative review —Journal of Medical Economics (May 2025) 
 

What is the purpose of this study? 
Although new treatments have greatly improved outcomes for people with blood cancers, major racial and ethnic disparities still exist, when it comes to access to care and treatment. Telehealth (using technology to deliver healthcare remotely) offers a promising way to reduce these gaps. However, successful telehealth not only depends on having the right technology, but also on supportive policies, strong internet infrastructure, and user training. 
 
This study emphasizes the need for expanding the use of telehealth in managing blood cancers, with the goal of improving both equity and patient outcomes. 
 

How was it conducted? 


The authors combined insights from a discussion among experts and patient advocates with a review of 18 research papers. Some studies looked at blood cancers broadly (like leukemia and lymphoma), while others focused on specific types. The telehealth strategies fell into two main groups: 

1. Electronic consultations between patients and healthcare providers (10 studies) 
2. Targeted interventions to improve patient health (8 studies) 

 
Why this study matters 


The studies showed a variety of benefits from telehealth, including: 

1. Better quality of life for patients 
2. Greater acceptance and use by both patients and doctors 
3. Improved treatment adherence 
4. Lower healthcare costs and resource use 

 
In conclusion, early evidence suggests telehealth can improve care and reduce costs for blood cancer patients. However, because the research was done in different settings with different approaches, more studies are needed. Health systems also need stronger data to understand the economic benefits of telehealth, especially in diagnosis and treatment access. 
 
Reference: 
Mikhael, J., Darlington, D., et. al (2025). The benefits of telehealth in promoting equity in blood cancer care – results of a multi-stakeholder forum and systematic literature review. Journal of Medical Economics, 28(1), 788–802. https://doi.org/10.1080/13696998.2024.2438561 (https://www.tandfonline.com/doi/full/10.1080/13696998.2024.2438561) 
 

Clinical Trials 
 

Phase 2 iMMagine-1 Study of Anito-cel in Patients with RRMM 
 

In a press release, (https://www.businesswire.com/news/home/20250513572727/en/Arcellx-Announces-New-Positive-Data-for-Its-iMMagine-1-Study-in-Patients-with-Relapsed-andor-Refractory-Multiple-Myeloma) clinical-stage biotechnology company Arcellx announced the positive results from the Phase 2 iMMagine-1 study:  
 

• 117 patients dosed with  anitocabtagene autoleucel (anito-cel) “demonstrated 97% overall response rate (ORR) and 68% complete response/stringent complete response (CR/sCR) at a median follow-up of 12.6 months” 
• There were no observations of delayed neurotoxicities, Parkinsonism, cranial nerve palsies, Guillain-Barré syndrome, nor immune-mediated enterocolitis with the use of anito-cel 
• “Of those evaluable for minimal residual disease (MRD) testing at the time of this data cut, 93.3% achieved MRD negativity at a minimum of 10^-5 sensitivity. Six-month progression-free survival (PFS) and overall survival (OS) rates were 91.9% and 96.6%, respectively, and 12-month PFS and OS rates were 78.8% and 95.2%, respectively. Median PFS and median OS have not been reached.” 
• The iMMagine-1 data will be presented during an oral presentation at EHA 2025 Congress in Milan, Italy on June 14 

 
According to Arcellx Chairman and Chief Executive Officer Rami Elghandour, “these clinical data from our registrational study continue to support our belief that anito-cel has the potential to address the needs of myeloma patients and the physicians who serve them.” 
 
“We believe there remains an unmet medical need for CAR-T therapies that are efficacious, safe, and accessible. Anito-cel has the unique potential to address these needs thanks to our differentiated technology, our incredible and entrepreneurial team, the robust clinical data generated to date, and our strong partnership with Kite. We look forward to sharing these data with the clinical community at EHA and are honored that the iMMagine-1 data will be presented during an oral presentation on Saturday, June 14,” he further stated. 
 

UK Myeloma Research Alliance Myeloma XII (ACCoRD) Trial 
 

Findings of the clinical trial funded by Stand Up To Cancer, Cancer Research UK, and Takeda Oncology revealed “an innovative blood cancer treatment regime that could extend remission by 7 months on average,” said the University of Leeds in a news article.  (https://www.leeds.ac.uk/main-index/news/article/5781/extending-blood-cancer-remission)

 
The clinical trial, published in The Lancet Haematology (https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(24)00249-7/fulltext)(2024), was conducted in 79 hospitals in the UK where relapsed/refractory myeloma patients had to undergo a second stem cell transplant taken from their own bone marrow while using thalidomide, dexamethasone, and ixazomib after transplant as alternatives to chemotherapy. 

 
The results revealed “extended disease-free survival by 7 months compared with regular treatment.”  
 
“Not only did the ACCoRd trial improve patients’ time free from myeloma, it showed that using these drugs can also improve patients’ quality of life compared to using chemotherapy or long-term steroid use. Smarter, kinder treatments are a key part of the work we’re doing at the Leeds Cancer Research Centre,” said Prof. Gordon Cook, Professor of Haematology and Director of the Leeds Cancer Research Center at the University of Leeds, who also leads the trial.  
 

Drug Authorizations for RRMM Treatments 
 

Lynozyfic™ (linvoseltamab) Granted Conditional Marketing Approval by the European Commission for Treatment of RRMM Patients 
 

On April 28, Regeneron Pharmaceuticals, Inc. announced through a press release (https://newsroom.regeneron.com/news-releases/news-release-details/lynozyfictm-linvoseltamab-approved-european-union-treatment) that the European Commission (EC) has granted conditional marketing approval for Lynozyfic™ (linvoseltamab) for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM).  

 
Linvoseltamab is a treatment for myeloma patients who have already tried at least three other therapies, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody, and whose disease has progressed after last treatment. 
 
A bispecific antibody, linvoseltamab is designed to bridge B-cell maturation antigen (BCMA) on myeloma cells with CD3-expressing T cells that help attack cancer cells. 
 
Linvoseltamab is the first approved BCMAxCD3 therapy that can be given every four weeks, if the patient has had a strong response (called a very good partial response or better) after at least 24 weeks of treatment. The regimen requires careful monitoring near a specialized medical center during the early doses to make sure it’s safe, especially for the first 24 hours after the first dose and another 24 hours after the second step-up dose. 
 

Blenrep (belantamab mafodotin) Combinations Authorized by UK MHRA and Japan’s Ministry of Health for Treatment of RRMM Patients 
 

On April 17, the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK authorized the use of Blenrep (belantamab mafodotin) for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM), “in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide. This UK regulatory authorization marks the first in the world for Blenrep in this treatment setting,” states GSK in a press release (https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-by-uk-mhra-in-relapsedrefractory-multiple-myeloma/). 

 
According to GSK, Blenrep has shown “superior efficacy in two head-to-head phase III trials (DREAMM-7 and DREAMM-8), including overall survival in the DREAMM-7 trial.” 
 
“As patients with multiple myeloma increasingly receive combination therapies at diagnosis, treatment options available in the community setting that use different mechanisms like Blenrep are crucial to extending remission and ultimately survival. We are pleased to see this advancement in the treatment landscape extended across both academic and community settings where many patients are treated,” said IMF Chief Medical Officer Dr. Joseph Mikhael. 
 
A month later, on May 19, Japan’s Ministry of Health, Labour and Welfare (MHLW) also approved Blenrep combinations for the treatment of RRMM patients. “The approval follows an orphan drug designation for Blenrep in Japan, which was granted based on its ability to address high unmet need for patients with multiple myeloma,” notes GSK in its press release. (https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-japan/)  

 

U.S. Food and Drug Administration (FDA) 
 

Ichnos Glenmark Innovation (IGI) Granted FDA Fast Track Designation for ISB 2001 for RRMM 
 

In a press release (https://www.globenewswire.com/news-release/2025/05/05/3073932/0/en/Ichnos-Glenmark-Innovation-IGI-Receives-U-S-FDA-Fast-Track-Designation-for-ISB-2001-for-Relapsed-Refractory-Multiple-Myeloma.html) on May 5, clinical-stage biotechnology company Ichnos Glenmark Innovation (IGI) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ISB 2001. 
 
“This important designation was granted for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. ISB 2001 is an investigational trispecific antibody therapeutic that targets BCMA and CD38 on myeloma cells and CD3 on T cells. ISB 2001 is currently being evaluated in a Phase 1 dose-expansion study,” states the press release.  
 
The dose-escalation portion of IGI’s Phase 1 clinical study in patients with heavily pretreated multiple myeloma has been recently completed, with results to be presented in a rapid oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on Monday, June 2. 
 
IGI President & CEO Cyril Konto, MD said: “At IGI, we have long recognized the urgent need for novel treatment options – particularly for patients who have already received first-generation bispecifics or CAR T-cell therapies. Our trispecific candidate is designed to enhance tumor targeting while reducing on-target, off-tumor toxicity. We are honored to receive this Fast Track designation and look forward to working closely with the FDA to advance our Multispecific™ T-cell engager, with the goal of delivering a first-in-class therapy for patients with relapsed or refractory multiple myeloma.” 
 

 

FDA ODAC votes in favor of the benefit-risk profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for HR SMM 
 

On May 20, Johnson & Johnson announced via a press release (https://www.jnj.com/media-center/press-releases/u-s-fda-oncologic-drugs-advisory-committee-votes-in-favor-of-the-benefit-risk-profile-of-darzalex-faspro-daratumumab-and-hyaluronidase-fihj-for-high-risk-smoldering-multiple-myeloma)that the FDA Oncologic Drugs Advisory Committee (ODAC) has voted in favor (6-2) of the benefit-risk profile of Darzalex Faspro (daratumumab and hyaluronidase-fihj) for high-risk smoldering multiple myeloma (HR SMM).  

The ODAC’s recommendation was based on the positive progression-free survival (PFS) and clinical benefit outcomes in the Phase 3 AQUILA study.  
 
“The vote highlights a pivotal moment in the care of patients most likely to develop active multiple myeloma, potentially altering the course of disease and treatment,” states the press release. 
 
As a foundational therapy in myeloma, Darzalex Faspro “would provide a potential path for earlier intervention,” if approved by the FDA for this indication. Currently, no treatments have been approved by the FDA for high-risk smoldering myeloma.  
 
According to Johnson & Johnson Innovative Medicine Vice President of Oncology Clinical Research Sen Zhuang MD, “early intervention in high-risk smoldering multiple myeloma demonstrated a reduction in the risk of progression or death.” 
 
“The proactive approach demonstrated in the AQUILA study is an example of Johnson & Johnson’s aspiration to get in front of cancer by providing a platform to treat disease before progression to active disease,” he further said. 
 
“The ODAC is convened upon request of the FDA to review and evaluate safety and efficacy data of human drug products for use in the treatment of oncologic diseases. The committee provides non-binding recommendations based on its evaluation; however, final decisions on approval of the drug are made by the FDA,” notes the press release. 
 
In case you missed it, you can still watch the recorded video of the ODAC Meeting (https://www.youtube.com/live/iSGFdhMgh1E) on YouTube.
 

Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) 
 

Blenrep (belantamab mafodotin) combinations receive positive CHMP opinion in RRMM 
 

On May 23, GSK announced in a press release (https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-receive-positive-chmp-opinion-in-relapsedrefractory-multiple-myeloma/) that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) “has recommended the approval of Blenrep for the treatment of adults with relapsed or refractory multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide,” with an approval decision expected in Q3 of 2025. 
 
Results from the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed/refractory multiple myeloma showed superior efficacy, supporting the CHMP opinion. “These include statistically significant and clinically meaningful progression-free survival (PFS) results for Blenrep combinations versus standards of care in both trials and overall survival (OS) versus a daratumumab-based triplet in DREAMM-7. The safety and tolerability profiles of the Blenrep combinations were broadly consistent with the known profiles of the individual agents,” states the press release. 
 
“[This] positive CHMP opinion is an important milestone toward bringing the benefits of Blenrep combinations to patients with multiple myeloma in Europe. Blenrep is well positioned to address the unmet needs of these patients while also providing the benefit of in-office administration in both academic and community treatment settings without complex pre-administration regimens or hospitalization,” said Hesham Abdullah, GSK Senior Vice President, Global Head Oncology, R&D.