REG - GSK PLC - Blenrep approved by US FDA in multiple myeloma

GSKAnnouncement

24/10/2025 07:00

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RNS Number : 6589E  GSK PLC  24 October 2025

Issued: 23 October 2025, London UK

 

 

Blenrep approved by US FDA for use in treatment of relapsed/refractory
multiple myeloma

·   Significant unmet need for patients requires new and novel
treatments(( 1  (#_edn1) ))

·   DREAMM-7 showed a 51% reduction in the risk of death and tripled median
progression-free survival in 3L+ indicated population versus a
daratumumab-based triplet 2  (#_edn2)

·   Blenrep is the only anti-BCMA accessible in the community setting where
70% of patients receive care, and with a new streamlined REMS programme 3 
(#_edn3)

·   Robust clinical development is ongoing to advance Blenrep in earlier
lines of treatment, including newly diagnosed patients(( 4  (#_edn4) ))

 

GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration
(FDA) has approved Blenrep (belantamab mafodotin-blmf) in combination with
bortezomib and dexamethasone (BVd) for the treatment of adult patients with
relapsed or refractory multiple myeloma who have received at least two prior
lines of therapy, including a proteasome inhibitor (PI) and an
immunomodulatory (IMID) agent.

 

The Blenrep approval is supported by data from the pivotal DREAMM-7 phase III
trial. In patients who had two or more prior lines of therapy (3L+), including
a PI and an IMID, Blenrep in combination demonstrated a clinically meaningful
51% reduction in the risk of death [HR 0.49, 95% confidence interval (CI):
0.32-0.76] and a tripled median progression-free survival (PFS) of 31.3 months
[95% CI: 23.5-NR)] versus 10.4 months [95% CI: 7.0-13.4] for a
daratumumab-based triplet (DVd) [HR 0.31, 95% CI: 0.21-0.47]. The safety and
tolerability profiles of the Blenrep combination were broadly consistent with
the known profiles of the individual agents.(2)

( )

Tony Wood, Chief Scientific Officer, GSK, said: "Today's FDA approval of
Blenrep is another significant milestone, providing potential for superior
efficacy, including overall survival, to US patients. There is an urgent need
for new and novel therapies, as nearly all patients with multiple myeloma
experience relapse and re-treating with the same mechanism of action often
leads to suboptimal outcomes. As the only anti-BCMA agent that can be
administered across healthcare settings, including in community centres where
70% of patients receive care, Blenrep fulfils a major patient need. We believe
Blenrep can redefine treatment for patients with multiple myeloma in all parts
of the world, and we are accelerating its development in earlier lines of
therapy to support its use across all stages of this difficult-to-treat
cancer."

 

Working closely with the FDA, Blenrep is available through a new, streamlined
Risk Evaluation and Mitigation Strategy (REMS). The new REMS supports
appropriate use and patient safety while reducing administrative burden
through simplified patient forms, removal of duplicative checklists and
efficient communication between HCPs and either optometrists or
ophthalmologists monitoring eye care. GSK will also offer Together with GSK,
an optional patient support programme available to all US patients prescribed
Blenrep.

 

Data from the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma)
clinical trial programme will be submitted to the National Comprehensive
Cancer Network (NCCN) guidelines this year. Recent results from the DREAMM
studies, alongside emerging real-world evidence, provide a growing body of
data for Blenrep. 5  (#_edn5) (, 6  (#_edn6) )

 

Sagar Lonial, MD, Chief Medical Officer, Winship Cancer Institute of Emory
University in Atlanta, Georgia, Chair of Emory Department of Hematology and
Medical Oncology, said: "With the approval of Blenrep, we now have a
community-accessible BCMA-targeting agent with the potential to improve
outcomes for patients following two or more prior lines of treatment, where
options are limited. This approval marks an important advance in the US
relapsed/refractory treatment landscape."

 

Michael Andreini, President and Chief Executive Officer of the Multiple
Myeloma Research Foundation and the Multiple Myeloma Research Consortium,
said: "The reality for most patients with multiple myeloma is a relentless
cycle of remission and relapse, as their disease becomes refractory to
treatments. Patients urgently need more effective treatment options that can
offer more quality time with their loved ones. We see the potential for
Blenrep in combination to help patients achieve this."

 

GSK is advancing the DREAMM clinical programme to demonstrate Blenrep's
potential benefit in earlier lines of treatment. Follow-up continues for
overall survival (OS) in both DREAMM-7 and DREAMM-8 with data expected in
early 2028, including in patients who have received only one prior line of
therapy. DREAMM-10, a phase III trial in newly diagnosed transplant-ineligible
patients, which represent over 70% of patients starting therapy, was initiated
in Q4-2024.(4) Interim efficacy and safety data for Blenrep as a first line
treatment are expected in early 2028 with enrolment expanded to US sites to
increase US patient representation in the study population. GSK continues to
work with the FDA for US patients.

 

Approvals outside of the US

Blenrep combinations are approved in 2L+ relapsed or refractory multiple
myeloma in the European Union
(https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-eu-for-treatment-of-relapsedrefractory-multiple-myeloma/)
 7  (#_edn7) , UK
(https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-by-uk-mhra-in-relapsedrefractory-multiple-myeloma/)
 8  (#_edn8) , Japan
(https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-japan/)
 9  (#_edn9) , Canada, Switzerland and Brazil. Applications are currently
under review in other markets globally, including China
(https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combination-accepted-for-priority-review-in-china-in-relapsedrefractory-multiple-myeloma/)
 10  (#_edn10) where the application is based on the results of DREAMM-7 and
has been granted Breakthrough Therapy Designation and Priority Review.

 

About multiple myeloma

Multiple myeloma is the third most common blood cancer globally and is
generally considered treatable but not curable. 11  (#_edn11) (, 12  (#_edn12)
) There are approximately 180,000 new cases of multiple myeloma diagnosed
globally each year. 13  (#_edn13) Research into new therapies is needed as
multiple myeloma commonly becomes refractory to available treatments. 14 
(#_edn14) Many patients with multiple myeloma, including approximately 70% in
the US, 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.(3)(,( 15  (#_edn15) )),( 16  (#_edn16) )

 

About Blenrep

Blenrep is a monoclonal ADC (antibody-drug conjugate) comprising a humanised
BCMA (B-cell maturation antigen) 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 the US, Blenrep is indicated in combination with bortezomib and
dexamethasone (BVd) for the treatment of adult patients with relapsed or
refractory multiple myeloma who have received at least two prior lines of
therapy, including a proteasome inhibitor and an immunomodulatory agent.

 

Please see accompanying US Prescribing Information which will soon be
available here
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Blenrep/pdf/BLENREP-PI-MG.PDF)
 17  (#_edn17) .

 

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 r
(https://www.gsk.com/en-gb/media/press-releases/dreamm-7-phase-iii-trial-shows-pfs-improvement-and-strong-os-trend-for-blenrep-combo-versus-soc-combo-in-multiple-myeloma/)
esults
(https://www.gsk.com/en-gb/media/press-releases/dreamm-7-phase-iii-trial-shows-pfs-improvement-and-strong-os-trend-for-blenrep-combo-versus-soc-combo-in-multiple-myeloma/)
 18  (#_edn18) 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
(https://www.gsk.com/en-gb/media/press-releases/blenrep-shows-significant-overall-survival-benefit-reducing-the-risk-of-death-by-42-in-multiple-myeloma-at-or-after-first-relapse/)
 19  (#_edn19) were presented at the American Society of Hematology (ASH)
Annual Meeting in December 2024.

 

About DREAMM-10

DREAMM-10 is a multicentre, open-label, randomised phase III clinical trial in
newly diagnosed transplant ineligible patients with multiple myeloma,
evaluating belantamab mafodotin plus lenalidomide and dexamethasone (BRd)
versus daratumumab plus lenalidomide and dexamethasone (DRd).(4)

 

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 gsk.com.

 

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Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made
by GSK, including those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from those
projected. Such factors include, but are not limited to, those described in
the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2024, and
GSK's Q2 Results for 2025.

 

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WC1A 1DG

 1  (#_ednref1) Bruno A, et al. Recent real-world treatment patterns and
outcomes in US patients with relapsed/refractory multiple myeloma. Expert
Review of Hematology. 2020; Volume 13, Issue 9:1017-1025
https://www.tandfonline.com/doi/full/10.1080/17474086.2020.1800451.

 2  (#_ednref2) Blenrep US Prescribing Information.

 3  (#_ednref3) Komodo claims data. Accessed 25 September 2025.

 4  (#_ednref4) ClinicalTrials.gov. National Library of Medicine (US).
Identifier NCT06679101, A Study of Belantamab Mafodotin Administered in
Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab,
Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed
Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell
Transplantation (TI-NDMM) (DREAMM-10). Available at:
https://clinicaltrials.gov/study/NCT06679101.

 5  (#_ednref5) 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.

 6  (#_ednref6) 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.

 7  (#_ednref7) GSK press release issued 24 July 2025. Blenrep (belantamab
mafodotin) combinations approved in EU for treatment of relapsed/refractory
multiple myeloma. Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-eu-for-treatment-of-relapsedrefractory-multiple-myeloma/.

 8  (#_ednref8) GSK press release issued 17 April 2025. Blenrep (belantamab
mafodotin) combinations approved by UK MHRA in relapsed/refractory multiple
myeloma. Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-by-uk-mhra-in-relapsedrefractory-multiple-myeloma/.

 9  (#_ednref9) GSK press release issued 19 May 2025. Blenrep (belantamab
mafodotin) combinations approved in Japan for treatment of relapsed/refractory
multiple myeloma. Available at
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-japan/.

 10  (#_ednref10) GSK press release issued 9 December 2024. Blenrep
(belantamab mafodotin) combination accepted for priority review in China in
relapsed/refractory multiple myeloma. Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combination-accepted-for-priority-review-in-china-in-relapsedrefractory-multiple-myeloma/.

 11  (#_ednref11) 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.

 12  (#_ednref12) 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.

 13  (#_ednref13) Global Cancer Observatory. International Agency for Research
on Cancer. World Health Organization. Multiple Myeloma fact sheet. Available
at:
https://gco.iarc.who.int/media/globocan/factsheets/cancers/35-multiple-myeloma-fact-sheet.pdf.
Accessed 5 March 2025.

 14  (#_ednref14) Nooka AK, Kastritis E, Dimopoulos MA. Treatment options for
relapsed and refractory multiple myeloma. Blood. 2015;125(20).
doi:10.1182/blood-2014-11-568923.

 15  (#_ednref15) 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.

 16  (#_ednref16) 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.

 17  (#_ednref17) US Prescribing Information. To be available at:
https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Blenrep/pdf/BLENREP-PI-MG.PDF.

 18  (#_ednref18) GSK press release issued 05 February 2024. DREAMM-7 phase
III trial shows Blenrep combination nearly tripled median progression-free
survival versus standard of care combination in patients with
relapsed/refractory multiple myeloma. Available at:
https://www.gsk.com/en-gb/media/press-releases/dreamm-7-phase-iii-trial-shows-pfs-improvement-and-strong-os-trend-for-blenrep-combo-versus-soc-combo-in-multiple-myeloma/.

 19  (#_ednref19) GSK press release issued 09 December 2024. Blenrep shows
significant overall survival benefit, reducing the risk of death by 42% in
multiple myeloma at or after first relapse. Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-shows-significant-overall-survival-benefit-reducing-the-risk-of-death-by-42-in-multiple-myeloma-at-or-after-first-relapse/.

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