GSK's Blenrep (belantamab mafodotin) combinations approved in Singapore for treatment of relapsed/refractory multiple myeloma

• Two head-to-head phase III trials demonstrated superior efficacy, including overall survival versus a daratumumab-based triplet in DREAMM-7
• Blenrep, a first-in-class anti-BCMA ADC, could transform treatment as early as first relapse where additional effective treatment options are needed^[1],[2],[3]

SINGAPORE, Aug. 19, 2026 /PRNewswire/ — GSK Singapore today announced that the Singapore Health Sciences Authority (HSA) has approved 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.

The approval is based on the favourable benefit risk profile of Blenrep combinations, with efficacy demonstrated in the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple myeloma. These include statistically significant and clinically meaningful progression-free survival (PFS) for Blenrep combinations versus triplet standard of care combinations in both trials and overall survival (OS) versus a daratumumab-based triplet in DREAMM-7.^[2],[3],[4] The safety and tolerability profiles of the Blenrep combinations were broadly consistent with the known profiles of the individual agents.^[2],[3]

Aldo Amador Navarro Rojas, Country Medical Director Singapore, GSK, said: "Today’s approval of Blenrep combinations is a redefining moment for patients with relapsed or refractory multiple myeloma in Singapore. While significant progress has been made in the management of multiple myeloma, most patients will eventually experience relapse, highlighting the need for new treatment options that can help extend remission, prolong survival and support quality of life. Backed by the robust results of the DREAMM clinical trial programme, Blenrep offers a differentiated mechanism of action and represents an important addition to the treatment landscape for patients from first relapse onward. "

Approximately 100 to 120 people per year are diagnosed with multiple myeloma in Singapore.^[5] Blenrep is the only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC) approved in multiple myeloma, providing patients with a differentiated mechanism of action to potentially help slow disease progression and extend survival.^[1] Blenrep combinations provide myeloma patients with additional BCMA-targeting options, which can easily be administered in outpatient settings.

Prof Chng Wee Joo, Senior Consultant, Division of Haematology, Department of Haematology-Oncology, National University Cancer Institute, Singapore, said: "The approval of Blenrep combinations in Singapore adds a new treatment option with a differentiated mechanism of action for patients with relapsed or refractory multiple myeloma. In the DREAMM-7 and DREAMM-8 studies, these regimens demonstrated robust efficacy and can be administered in outpatient settings. These findings suggest the potential to help some patients achieve longer periods of remission while maintaining quality of life and improving outcomes. Importantly, as more patients are living longer with multiple myeloma, preserving quality of life has become an increasingly important treatment goal alongside prolonging survival. This approval expands the available treatment options in the multiple myeloma landscape and provides clinicians with an additional choice for appropriate patients from first relapse onward."

Dr Chandramouli Nagarajan, Senior Consultant, Department of Haematology, Singapore General Hospital, said, "The treatment paradigm of multiple myeloma (MM) is constantly evolving due to new research and identification of newer targets on myeloma cancer cells like B-cell maturation antigen (BCMA) that can be exploited to gain control of the disease. Belantamab mafodotin, in combination with bortezomib or pomalidomide, and dexamethasone, has demonstrated the potential to extend remission and survival effectively through the DREAMM-7 and DREAMM-8 trials. Given the less frequent infusion schedule compared to the current standard of care in relapsed/refractory MM, patients also get to maintain their independence, have time to pursue their meaningful daily activities, and spend valuable time with their loved ones. With the approval of these combinations in Singapore, we have additional options on hand to better support our patients through a fundamentally different approach in the management of relapsed and refractory myeloma patients."

Both DREAMM-7 and DREAMM-8 showed statistically significant and clinically meaningful PFS improvements for the Blenrep combinations compared to standard of care triplet combinations in the second line or later treatment of multiple myeloma.^[2],[3] In DREAMM-7, the Blenrep combination (n=243) nearly tripled median PFS versus the daratumumab-based comparator (n=251) (36.6 months versus 13.4 months, respectively (hazard ratio [HR]: 0.41 [95% confidence interval (CI): 0.31-0.53], p-value<0.00001).^[2] DREAMM-7 also met the key secondary endpoint of OS, showing a statistically significant and clinically meaningful 42% reduction in the risk of death at a median follow-up of 39.4 months favouring the Blenrep combination versus the daratumumab-based comparator (HR: 0.58; 95% CI: 0.43-0.79; p=0.00023). The median OS was not reached in either arm of the study. The three-year OS rate was 74% in the Blenrep combination arm and 60% in the daratumumab combination arm.^[4]

In DREAMM-8, at a median follow-up of 21.8 months, the median PFS was not yet reached (95% CI: 20.6-not yet reached [NR]) with the Blenrep combination compared to 12.7 months in the bortezomib combination (95% CI: 9.1-18.5) at the time of primary analysis.^[3]

Blenrep combinations consistently benefited a broad range of patients, including those with poor prognostic features or outcomes, such as high-risk cytogenetics or those refractory to lenalidomide. Both trials also showed clinically meaningful improvements across all other secondary efficacy endpoints, including deeper and more durable responses versus the respective comparators.^[2],[3]

DREAMM-7 and DREAMM-8 showed that eye-related side effects associated with Blenrep can be managed and reversed with appropriate dose modifications and follow-up. This allowed patients to maintain benefit and resulted in low rates of discontinuation due to eye-related side effects (≤9%) in both trials.^[2],[3] The most commonly reported non-ocular adverse events (>30% of participants) in the Blenrep combination arm were thrombocytopenia (87%) and diarrhoea (32%) in DREAMM-7, and neutropenia (63%), thrombocytopenia (55%) and COVID-19 (37%) in DREAMM-8.^[2],[3]

About multiple myeloma

Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.^[6],[7] There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year.^[5] Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.^[1] Many patients with multiple myeloma are treated in a community cancer setting, leaving an urgent need for new, effective therapies with manageable side effects that can be administered outside of an academic centre.^[8],[9]

About Blenrep

Blenrep is an ADC comprising a humanised BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.

Indication

In Singapore, Blenrep is indicated in adults for the treatment of relapsed or refractory multiple myeloma:

• in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and
• in combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide.

IMPORTANT SAFETY INFORMATION FOR BLENREP

Refer to the Blenrep Prescribing Information^[10] for the full list of adverse events and the complete important safety information in Singapore.

About DREAMM-7

DREAMM-7 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin combined with bortezomib plus dexamethasone (BVd) compared to daratumumab combined with bortezomib plus dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy, with documented disease progression during or after their most recent therapy. The trial enrolled 494 participants who were randomised 1:1 to receive either BVd or DVd. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously every three weeks in combination for the first eight cycles and then continued as a single agent. The primary endpoint was PFS as per an independent review committee, with secondary endpoints including OS, duration of response (DOR), and minimal residual disease (MRD) negativity rate as assessed by next-generation sequencing. Other secondary endpoints include overall response rate (ORR), safety, and patient reported and quality of life outcomes.

PFS results were presented at the American Society of Clinical Oncology (ASCO) Plenary Series in February 2024 and published in the New England Journal of Medicine. OS results were presented at the American Society of Hematology (ASH) Annual Meeting in December 2024.^[2],[4]

About DREAMM-8

DREAMM-8 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin in combination with pomalidomide plus dexamethasone (BPd) compared to bortezomib and pomalidomide plus dexamethasone (PVd) in patients with relapsed or refractory multiple myeloma previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen, and who have documented disease progression during or after their most recent therapy. The trial included 302 participants who were randomised 1:1 to receive either BPd or PVd. Compared to the patient population studied in the DREAMM-7 trial, patients in DREAMM-8 were more heavily pre-treated in that all had prior exposure to lenalidomide, 78% were refractory to lenalidomide, 25% had prior daratumumab exposure and of those most were daratumumab refractory. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously for the first cycle and then 1.9mg/kg intravenously every four weeks. The primary endpoint was PFS as per an independent review committee, with key secondary endpoints including OS and MRD negativity rate as assessed by next-generation sequencing. Other secondary endpoints include ORR, DOR, safety, and patient reported and quality of life outcomes.

Results were first presented at the 2024 ASCO Annual Meeting and published in the New England Journal of Medicine.^[3] Updated PFS results were presented at the European Hematology Association (EHA) Congress in June 2025.^[11]

Information on indication, dosing, and contraindications per Blenrep Singapore Prescribing Information.

GSK in Oncology

Our ambition in oncology is to help increase overall quality of life, maximise survival and change the course of disease, expanding from our current focus on blood and women’s cancers into lung and gastrointestinal cancers, as well as other solid tumours. This includes accelerating priority programmes such as antibody-drug conjugates targeting B7-H3 and B7-H4, and IDRX-42, a highly selective KIT tyrosine kinase inhibitor.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at https://www.gsk.com/en-gb/locations/singapore/

References

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