GSK’s Blenrep Combinations Receive Positive CHMP Opinion for Relapsed or Refractory Multiple Myeloma, Signaling Expanded Access Across Europe
In a significant step forward for the treatment of multiple myeloma, GSK plc (LSE/NYSE: GSK) has announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific advisory arm of the European Medicines Agency (EMA), has issued a positive opinion recommending approval of Blenrep (belantamab mafodotin) in combination with standard-of-care regimens for adults with relapsed or refractory multiple myeloma (RRMM). The recommendation pertains to two distinct combination therapies: Blenrep with bortezomib and dexamethasone (BVd) for patients who have undergone at least one previous line of therapy, and Blenrep with pomalidomide and dexamethasone (BPd) for those previously treated with at least one therapy that included lenalidomide.
This regulatory milestone brings GSK one step closer to expanding the availability of Blenrep combinations across the European Union, with a final decision from the European Commission expected in the third quarter of 2025. Should the Commission follow the CHMP’s recommendation—as is typically the case—it would mark a major achievement in GSK’s oncology pipeline and provide new therapeutic options for thousands of patients across Europe grappling with this complex and often recurrent form of cancer.
A European Milestone Following Global Momentum
The CHMP’s positive recommendation follows a series of international approvals that reflect growing confidence in Blenrep’s clinical value. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved the same combination regimens in April 2025, and earlier this month, Japan’s Ministry of Health, Labour and Welfare granted marketing approval for the drug. These endorsements from leading regulatory bodies support the drug’s emerging profile as a potent anti-cancer agent that fills an important gap in the treatment landscape for multiple myeloma, particularly for patients who have become resistant to or have relapsed after standard therapies.
Blenrep’s potential to reshape treatment paradigms in multiple myeloma rests heavily on the robust clinical data generated in the pivotal Phase III DREAMM-7 and DREAMM-8 trials. These global studies demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) and, in the case of DREAMM-7, overall survival (OS) as well. In both trials, Blenrep-based regimens outperformed established standards of care, highlighting their therapeutic value in a patient population that remains underserved despite recent advances in treatment.
Groundbreaking Trial Data Underpin the CHMP Opinion
The DREAMM-7 trial evaluated Blenrep in combination with bortezomib and dexamethasone (BVd) against a control arm of daratumumab plus bortezomib and dexamethasone—a commonly used triplet regimen. The results revealed a substantial improvement in PFS and OS, confirming the clinical superiority of the Blenrep-based combination. DREAMM-8, meanwhile, studied Blenrep with pomalidomide and dexamethasone (BPd) in comparison to a control regimen of bortezomib, pomalidomide, and dexamethasone. The trial again demonstrated a significant improvement in progression-free survival, reinforcing Blenrep’s potential to become a new standard for patients who have relapsed after or become refractory to first-line therapies.
In both studies, safety and tolerability profiles of the Blenrep combinations were found to be consistent with the known adverse event profiles of the individual agents. Notably, ocular toxicity—a well-documented side effect of Blenrep—was shown to be manageable with appropriate dose modifications and ophthalmologic monitoring. Importantly, eye-related side effects did not generally result in treatment discontinuation, with dropout rates due to ocular events remaining at or below 9% in both trials.
Beyond ocular issues, the most frequently reported adverse events in the DREAMM-7 trial included thrombocytopenia, observed in 87% of patients, and diarrhea, affecting 32%. In DREAMM-8, neutropenia (63%), thrombocytopenia (55%), and COVID-19 (37%) were the most common non-ocular adverse events in the Blenrep treatment arm.
Blenrep’s Distinct Mechanism of Action
Blenrep is a first-in-class antibody-drug conjugate (ADC) targeting B-cell maturation antigen (BCMA), which is highly expressed on malignant plasma cells and plays a critical role in multiple myeloma pathogenesis. As the only approved anti-BCMA ADC for multiple myeloma, Blenrep offers a differentiated approach from other available therapies, including proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies.
By binding to BCMA on the surface of myeloma cells and delivering a cytotoxic agent directly into the tumor cell, Blenrep combines targeted immunotherapy with potent chemotherapeutic activity. This dual mechanism enhances its ability to kill cancer cells while limiting systemic toxicity—an important consideration in patients who are often elderly and heavily pre-treated.
Hesham Abdullah, Senior Vice President and Global Head of Oncology R&D at GSK, emphasized the significance of this progress:
“Today’s 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.”
This practical advantage is particularly meaningful in a disease that requires repeated treatment cycles and long-term monitoring. By eliminating the need for hospitalization or intricate pre-treatment steps, Blenrep has the potential to improve treatment adherence and reduce the burden on healthcare systems.
A Disease Marked by Inevitable Relapse
Multiple myeloma is a hematologic cancer that arises from plasma cells in the bone marrow. Despite advances in treatment that have extended survival, it remains incurable for the vast majority of patients. Approximately 50,000 new cases are diagnosed annually in Europe, and nearly all patients eventually relapse after their initial course of therapy. As disease resistance increases over time, patients require multiple lines of therapy, often with diminishing returns in efficacy.
The introduction of Blenrep-based regimens into earlier lines of therapy, as supported by the DREAMM-7 and DREAMM-8 trials, could help shift the treatment paradigm. These combinations offer new hope to patients facing relapse, potentially delaying disease progression and improving quality of life without requiring invasive procedures or hospitalization.
Regulatory Reviews Underway Worldwide
In addition to its progress in Europe, GSK is pursuing regulatory approvals for Blenrep combinations in multiple global markets. In the United States, the Food and Drug Administration (FDA) is currently reviewing the data with a Prescription Drug User Fee Act (PDUFA) target action date set for July 23, 2025. The U.S. submission includes both the DREAMM-7 and DREAMM-8 trials.
China’s regulatory agency is also evaluating Blenrep’s combination with BVd, supported by a Breakthrough Therapy Designation and priority review status, underscoring the urgency of bringing this treatment to patients in need. Submissions are additionally under review in Canada and Switzerland, with the latter country granting priority review for the DREAMM-8 data.
With the CHMP’s endorsement and approvals already secured in the UK and Japan, GSK is on track to establish Blenrep as a cornerstone treatment in the evolving landscape of multiple myeloma care. The EMA’s pending decision, expected later this year, could open the door to broader access across Europe and solidify Blenrep’s role in addressing one of the most challenging hematologic malignancies.
As GSK continues to pursue approvals in other regions, patients and providers alike are increasingly hopeful that the promise of Blenrep combinations will translate into longer survival and improved quality of life for those battling relapsed or refractory multiple myeloma.
