REG - GSK PLC - US FDA review extended for Blenrep

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RNS Number : 2937S  GSK PLC  23 July 2025

Issued: 23 July 2025, London UK

 

 

GSK announces extension of US Food and Drug Administration review period for
Blenrep (belantamab mafodotin-blmf) in relapsed/refractory multiple myeloma

 

·   New PDUFA date scheduled for 23 October 2025

 

 

GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration
(FDA) has extended the review period for the Biologics License Application
(BLA) for Blenrep combinations 1  (#_edn1) for the treatment of patients with
relapsed or refractory multiple myeloma who have received at least one prior
line of therapy. The new Prescription Drug User Fee Act (PDUFA) action date is
23 October 2025 and provides the FDA with time to review additional
information provided in support of the application.

 

The BLA is supported by efficacy results shown by Blenrep combinations 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 results for Blenrep combinations versus
triplet standard of care combinations in both trials and overall survival
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.

 

GSK is confident in the data supporting Blenrep combinations and looks forward
to ongoing constructive conversations with the FDA as they continue their
review.

 

Blenrep combinations are currently approved in the UK
(https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-by-uk-mhra-in-relapsedrefractory-multiple-myeloma/)
 2  (#_edn2) , Japan
(https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-japan/)
 3  (#_edn3) , Canada, Switzerland (DREAMM-8 only at this time) and the United
Arab Emirates. Applications are currently under review in all major markets
globally, including the EU
(https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-receive-positive-chmp-opinion-in-relapsedrefractory-multiple-myeloma/)
 4  (#_edn4) and China
(https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combination-accepted-for-priority-review-in-china-in-relapsedrefractory-multiple-myeloma/)
(( 5  (#_edn5) )) (based on the results of DREAMM-7, with Breakthrough Therapy
Designation for the combination and priority review for the application).

 

About multiple myeloma

Multiple myeloma is the third most common blood cancer globally and is
generally considered treatable but not curable. 6  (#_edn6) (, 7  (#_edn7) )
There are approximately more than 180,000 new cases of multiple myeloma
diagnosed globally each year. 8  (#_edn8) Research into new therapies is
needed as multiple myeloma commonly becomes refractory to available
treatments. 9  (#_edn9) 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. 10  (#_edn10) (, 11  (#_edn11) )

 

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

Blenrep combinations were approved in relapsed or refractory multiple myeloma
in the UK in April 2025.

 

In the UK, Blenrep is indicated in adults for the treatment of 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

More information can be found in the Blenrep Summary of Product
Characteristics and Patient Information leaflets available on the MHRA
Products website (https://products.mhra.gov.uk/) . 12  (#_edn12)

 

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 2.5 mg/kg intravenously every three weeks in
combination for the first eight cycles and then continued as a single agent.
The primary endpoint was progression-free survival (PFS) as per an independent
review committee, with secondary endpoints including overall survival (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.

 

In DREAMM-7, BVd nearly tripled median PFS versus DVd (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). 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
BVd (n=243) versus DVd (n=251) (HR 0.58; 95% CI: 0.43-0.79; p=0.00023). The
three-year OS rate was 74% in the BVd arm and 60% in the DVd arm.

 

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. 13  (#_edn13) (, 14  (#_edn14) )

 

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 2.5 mg/kg intravenously for the first
cycle and then 1.9 mg/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.

 

At the primary analysis 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). A positive OS trend was observed but not statistically significant
(HR: 0.77 [95% CI: 0.53-1.14]) at the interim analysis. OS follow-up continues
and further analyses are planned.

With additional follow-up, a clinically meaningful benefit continued to be
observed, with a near-tripling of the median PFS for the Blenrep combination
versus the bortezomib combination (32.6 months versus 12.5 months,
respectively (HR: 0.49 [95% CI: 0.35-0.68]). At the end of one year, 71% (95%
CI: 63-78) of patients in the BPd combination group compared to 51% (95% CI:
42-60) in the PVd combination group were alive and had not progressed. A
benefit for BPd was observed across all pre-specified subgroups including
those with poor prognostic features, such as patients who were refractory to
lenalidomide and patients with high-risk cytogenetics.

Results were first presented at the 2024 ASCO Annual Meeting and published in
the New England Journal of Medicine. 15  (#_edn15) Updated PFS results were
presented at European Hematology Association Congress (EHA) 2025. 16 
(#_edn16)

 

 

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 Q1 Results for 2025.

Registered in England & Wales:

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WC1A 1DG

 

 1  (#_ednref1) Belantamab mafodotin in combination with bortezomib plus
dexamethasone (BVd) and belantamab mafodotin in combination with pomalidomide
plus dexamethasone (BPd).

 2  (#_ednref2) 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/.

 3  (#_ednref3) 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/.

 4  (#_ednref4) GSK press release issued 23 May 2025. Blenrep (belantamab
mafodotin) combinations receive positive CHMP opinion in relapsed/refractory
multiple myeloma. Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-receive-positive-chmp-opinion-in-relapsedrefractory-multiple-myeloma/.

 5  (#_ednref5) 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/.

 6  (#_ednref6) 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.

 7  (#_ednref7) 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.

 8  (#_ednref8) 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.

 9  (#_ednref9) 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.

 10  (#_ednref10) 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.

 11  (#_ednref11) 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.

 12  (#_ednref12) Medicines & Healthcare products Regulatory Agency
website: https://products.mhra.gov.uk/.

 13  (#_ednref13) 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.

 14  (#_ednref14) 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.

 15  (#_ednref15) 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.

 16  (#_ednref16) 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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