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

- Link: https://www.thailand-business-news.com/pr-news/gsks-blenrep-belantamab-mafodotin-combinations-approved-in-singapore-for-treatment-of-relapsed-refractory-multiple-myeloma
- Published: 2026-08-19T09:00:00+07:00
- Author: PR Newswire

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 ◦ 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/](https://www.gsk.com/en-gb/locations/singapore/)

**References**

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[1] Nooka AK, Kastritis E, Dimopoulos MA, et al. Treatment options for relapsed and refractory multiple myeloma. Blood. 2015 May 14;125(20). doi:10.1182/blood-2014-11-568923.

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[2] Hungria V, Robak P, Hus M, et al. Belantamab Mafodotin, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024 Aug 1;391(5):393-407. doi: 10.1056/NEJMoa2405090. Epub 2024 Jun 1. PMID: 38828933.

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[3] Dimopoulos MA, Beksac M, Pour L, Delimpasi S et al. Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma. N Engl J Med. 2024 Aug 1;391(5):408-421. doi: 10.1056/NEJMoa2403407. Epub 2024 Jun 2. PMID: 38828951.

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[4] Hungria V, Robak P, H Marek, et al. Belantamab Mafodotin, Bortezomib, and Dexamethasone Vs Daratumumab, Bortezomib, and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Overall Survival Analysis and Updated Efficacy Outcomes of the Phase 3 Dreamm-7 Trial. Presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. December 2024.

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[5] de Mel S, Tso ACY, Soekojo CY, Ooi MG, Lim CC, Teo C, et al. Singapore Myeloma Study Group consensus guidelines for the management of patients with newly diagnosed multiple myeloma. Ann Acad Med Singap. 2025;54(9):561-584. doi:10.47102/annals-acadmedsg.202532.

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[6] Sung H, Ferlay J, Siegel R, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249. doi:10.3322/caac.21660.

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[7] Kazandjian D. Multiple myeloma epidemiology and survival: A unique malignancy. Semin Oncol. 2016;43(6):676–681.doi: 10.1053/j.seminoncol.2016.11.004.

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[8] Gajra A, Zalenski A, Sannareddy A, et al. Barriers to Chimeric Antigen Receptor T-Cell (CAR-T) Therapies in Clinical Practice. Pharmaceut Med. 2022 Jun;36(3):163-171. doi: 10.1007/s40290-022-00428-w. Epub 2022 Jun 7.

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[9] Crombie J, Graff T, Falchi L, et al. Consensus recommendations on the management of toxicity associated with CD3×CD20 bispecific antibody therapy Blood (2024) 143 (16): 1565–1575. doi: 10.1182/blood.2023022432.

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[10] BLENREP (belantamab mafodotin) Singapore Prescribing Information, 2026.

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[11] Dimopoulos MA, Beksac M, Pour L, et al. Updated results from phase 3 DREAMM-8 study of Belantamab Mafodotin, Pomalidomide and Dexamethasone versus Pomalidomide plus Bortezomib and Dexamethasone in relapsed/refractory multiple myeloma. HemaSphere | 2025;9(S1) 846 EHA 2025 Congress.

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