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[6-K] GSK plc Current Report (Foreign Issuer)

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GSK announced US FDA approval of Blenrep (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone (BVd) for adults with relapsed or refractory multiple myeloma after at least two prior therapies, including a PI and an IMID.

The approval is supported by phase III DREAMM-7, where the BVd combination cut the risk of death by 51% (HR 0.49; 95% CI: 0.32–0.76) and delivered a median progression-free survival of 31.3 months (95% CI: 23.5–NR) versus 10.4 months (95% CI: 7.0–13.4) for a daratumumab-based triplet (HR 0.31; 95% CI: 0.21–0.47). Safety was broadly consistent with known profiles.

Blenrep is described as the only anti-BCMA agent accessible across community settings and will be available under a new streamlined REMS. Follow-up for overall survival in DREAMM-7 and -8 continues, with data expected in early 2028, and the phase III DREAMM-10 first-line study is underway.

GSK ha annunciato l'approvazione da parte della US FDA di Blenrep (belantamab mafodotin-blmf) in combinazione con bortezomib e dexametasone (BVd) per adulti con mieloma multiplo recidivante o refrattario dopo almeno due terapie precedenti, inclusi un PI e un IMID.

L'approvazione è supportata dal trial di fase III DREAMM-7, dove la combinazione BVd ha ridotto il rischio di morte del 51% (HR 0.49; 95% CI: 0.32–0.76) e ha fornito una sopravvivenza libera da progressione mediana di 31.3 mesi (95% CI: 23.5–NR) rispetto a 10.4 mesi (95% CI: 7.0–13.4) per una tripla basata su daratumumab (HR 0.31; 95% CI: 0.21–0.47). La sicurezza è stata ampliamente coerente con i profili noti.

Blenrep è descritto come l'unico agente anti-BCMA accessibile anche in contesti comunitari e sarà disponibile sotto un nuovo REMS snellito. Il follow-up per la sopravvivenza globale in DREAMM-7 e -8 continua, con dati attesi all'inizio del 2028, e lo studio di fase III DREAMM-10 in prima linea è in corso.

GSK anunció la aprobación de la FDA de EE. UU. de Blenrep (belantamab mafodotin-blmf) en combinación con bortezomib y dexametasona (BVd) para adultos con mieloma múltiple recidivante o refractario tras al menos dos terapias previas, incluyendo un PI y un IMID.

La aprobación está respaldada por el ensayo de fase III DREAMM-7, donde la combinación BVd redujo el riesgo de muerte en un 51% (HR 0.49; 95% CI: 0.32–0.76) y mostró una mediana de supervivencia libre de progresión de 31.3 meses (95% CI: 23.5–NR) frente a 10.4 meses (95% CI: 7.0–13.4) para una tríada basada en daratumumab (HR 0.31; 95% CI: 0.21–0.47). La seguridad fue, en general, consistente con los perfiles conocidos.

Se describe a Blenrep como el único agente anti-BCMA accesible también en entornos comunitarios y estará disponible bajo un nuevo REMS simplificado. El seguimiento de la supervivencia global en DREAMM-7 y DREAMM-8 continúa, con datos esperados a principios de 2028, y el estudio en fase III DREAMM-10 en primera línea está en curso.

GSK가 Blenrep (belantamab mafodotin-blmf) 를 보르테조밥(bortezomib)과 덱사메타손(dexamethasone)과의 조합(BVd)으로 성인 재발 또는 난치성 다발성 골수종 환자에서 최소 두 차례의 이전 치료(PI 및 IMID 포함) 후 승인을 발표했습니다.

승인은 3상 DREAMM-7에서 뒷받침되며, BVd 조합은 사망 위험을 51% 감소시켰고(HR 0.49; 95% CI: 0.32–0.76) 중간 무진행 생존기간은 31.3개월(95% CI: 23.5–NR)으로 다라투무맙 기반 삼중요법에 비해 10.4개월(95% CI: 7.0–13.4) 이었습니다(HR 0.31; 95% CI: 0.21–0.47). 안전성은 알려진 프로파일과 대체로 일치했습니다.

Blenrep는 지역 의료 현장에서도 접근 가능한 유일한 anti-BCMA 제제로 설명되며, 새로 간소화된 REMS 하에 이용 가능할 것입니다. DREAMM-7 및 DREAMM-8의 전체 생존 추적은 계속되며, 2028년 초에 데이터가 기대되며, 1차 치료 연구인 DREAMM-10의 3상 연구가 진행 중입니다.

GSK a annoncé l'approbation par la FDA américaine de Blenrep (belantamab mafodotin-blmf) en association avec le bortézomib et la dexaméthasone (BVd) chez des adultes atteints de myélome multiple en rémission ou résistant après au moins deux traitements préalables, dont un inhibiteur protéasome (PI) et un IMiD.

L'approbation est soutenue par l'essai de phase III DREAMM-7, où la combinaison BVd a réduit le risque de décès de 51% (HR 0,49 ; IC à 95% : 0,32–0,76) et a donné une survie sans progression médiane de 31,3 mois (IC à 95% : 23,5–NR) contre 10,4 mois (IC à 95% : 7,0–13,4) pour une trithérapie à base de daratumumab (HR 0,31 ; IC à 95% : 0,21–0,47). La sécurité était largement cohérente avec les profils connus.

Le Blenrep est décrit comme le seul agent anti-BCMA accessible en milieu communautaire et sera disponible sous un nouveau REMS simplifié. Le suivi de la survie globale dans DREAMM-7 et DREAMM-8 se poursuit, avec des données attendues début 2028, et l'étude de phase III DREAMM-10 en première ligne est en cours.

GSK hat die Zulassung der US-amerikanischen FDA für Blenrep (belantamab mafodotin-blmf) in Kombination mit Bortezomib und Dexamethason (BVd) bei Erwachsenen mit rezidivierendem oder refraktärem Multiplen Myelom nach mindestens zwei vorherigen Therapien, einschließlich eines PI und eines IMiD, angekündigt.

Die Zulassung wird durch den phase-III‑Trial DREAMM-7 gestützt, in dem die BVd-Kombination das Sterberisiko um 51% senkte (HR 0,49; 95% KI: 0,32–0,76) und eine mediale progressionsfreie Überlebensdauer von 31,3 Monaten (95% KI: 23,5–NR) gegenüber 10,4 Monaten (95% KI: 7,0–13,4) für eine daratumumab-basierte Dreierkombination erzielte (HR 0,31; 95% KI: 0,21–0,47). Die Sicherheit entsprach im Großen und Ganzen den bekannten Profilen.

Blenrep wird als einziger anti-BCMA-Wirkstoff beschrieben, der auch in Gemeinschaftseinrichtungen zugänglich ist, und wird unter einem neuen, schlankeren REMS verfügbar sein. Die Nachverfolgung des Gesamtüberlebens in DREAMM-7 und -8 läuft weiter, mit Daten, die Anfang 2028 erwartet werden, und die Phase-III-Studie DREAMM-10 in der Erstlinie befindet sich im Aufbau.

GSK أعلنت موافقة إدارة الغذاء والدواء الأمريكية على Blenrep (belantamab mafodotin-blmf) بالاشتراك مع بورتسوميزوم وديكساميثازون (BVd) للبالغين المصابين بمالیلم متعدد الفِرِد أو المقاوم بعد تلقي علاجات سابقة بما لا يقل عن علاجين، بما في ذلك PI و IMID.

تدعم الموافقة نتائج تجربة المرحلة الثالثة DREAMM-7، حيث خفضت تركيبة BVd مخاطر الوفاة بنسبة 51% (HR 0.49؛ 95% CI: 0.32–0.76) وحققت فترة بقاء متوقعة دون تقدم مرضي وسيطة قدرها 31.3 شهراً (95% CI: 23.5–NR) مقابل 10.4 أشهر (95% CI: 7.0–13.4) لسلسلة ثلاثية تعتمد على دارتموموماب (HR 0.31؛ 95% CI: 0.21–0.47). السلامة كانت متوافقة عمومًا مع الملفات المعروفة.

وُصف بلينريبس بأنه الوكيل المضاد للـ BCMA الوحيد المتاح في بيئات المجتمع وسيكون متاحًا بموجب REMS مبسّط جديد. المتابعة من أجل البقاء على قيد الحياة الإجمالية في DREAMM-7 و DREAMM-8 مستمرة، مع بيانات متوقعة في أوائل 2028، والدراسة المرحلة الثالثة DREAMM-10 في الخط الأول قيد التنفيذ.

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Insights

FDA approval backed by phase III survival and PFS advantages.

GSK secured US approval for Blenrep in BVd for relapsed/refractory multiple myeloma after ≥2 prior lines. In DREAMM-7, BVd reduced risk of death by 51% (HR 0.49) and extended median PFS to 31.3 months versus 10.4 months for a daratumumab-based triplet. The filing notes safety was broadly consistent with component profiles.

Commercial reach may be aided by community accessibility and a streamlined REMS, which simplifies forms and coordination for required eye care monitoring. The label positions Blenrep as an anti-BCMA option that can be administered outside academic centers.

Ongoing follow-up for overall survival in DREAMM-7 and -8 and the phase III DREAMM-10 first-line trial are noted, with data expected in early 2028. Subsequent disclosures may clarify durability of benefit and usage across settings.

GSK ha annunciato l'approvazione da parte della US FDA di Blenrep (belantamab mafodotin-blmf) in combinazione con bortezomib e dexametasone (BVd) per adulti con mieloma multiplo recidivante o refrattario dopo almeno due terapie precedenti, inclusi un PI e un IMID.

L'approvazione è supportata dal trial di fase III DREAMM-7, dove la combinazione BVd ha ridotto il rischio di morte del 51% (HR 0.49; 95% CI: 0.32–0.76) e ha fornito una sopravvivenza libera da progressione mediana di 31.3 mesi (95% CI: 23.5–NR) rispetto a 10.4 mesi (95% CI: 7.0–13.4) per una tripla basata su daratumumab (HR 0.31; 95% CI: 0.21–0.47). La sicurezza è stata ampliamente coerente con i profili noti.

Blenrep è descritto come l'unico agente anti-BCMA accessibile anche in contesti comunitari e sarà disponibile sotto un nuovo REMS snellito. Il follow-up per la sopravvivenza globale in DREAMM-7 e -8 continua, con dati attesi all'inizio del 2028, e lo studio di fase III DREAMM-10 in prima linea è in corso.

GSK anunció la aprobación de la FDA de EE. UU. de Blenrep (belantamab mafodotin-blmf) en combinación con bortezomib y dexametasona (BVd) para adultos con mieloma múltiple recidivante o refractario tras al menos dos terapias previas, incluyendo un PI y un IMID.

La aprobación está respaldada por el ensayo de fase III DREAMM-7, donde la combinación BVd redujo el riesgo de muerte en un 51% (HR 0.49; 95% CI: 0.32–0.76) y mostró una mediana de supervivencia libre de progresión de 31.3 meses (95% CI: 23.5–NR) frente a 10.4 meses (95% CI: 7.0–13.4) para una tríada basada en daratumumab (HR 0.31; 95% CI: 0.21–0.47). La seguridad fue, en general, consistente con los perfiles conocidos.

Se describe a Blenrep como el único agente anti-BCMA accesible también en entornos comunitarios y estará disponible bajo un nuevo REMS simplificado. El seguimiento de la supervivencia global en DREAMM-7 y DREAMM-8 continúa, con datos esperados a principios de 2028, y el estudio en fase III DREAMM-10 en primera línea está en curso.

GSK가 Blenrep (belantamab mafodotin-blmf) 를 보르테조밥(bortezomib)과 덱사메타손(dexamethasone)과의 조합(BVd)으로 성인 재발 또는 난치성 다발성 골수종 환자에서 최소 두 차례의 이전 치료(PI 및 IMID 포함) 후 승인을 발표했습니다.

승인은 3상 DREAMM-7에서 뒷받침되며, BVd 조합은 사망 위험을 51% 감소시켰고(HR 0.49; 95% CI: 0.32–0.76) 중간 무진행 생존기간은 31.3개월(95% CI: 23.5–NR)으로 다라투무맙 기반 삼중요법에 비해 10.4개월(95% CI: 7.0–13.4) 이었습니다(HR 0.31; 95% CI: 0.21–0.47). 안전성은 알려진 프로파일과 대체로 일치했습니다.

Blenrep는 지역 의료 현장에서도 접근 가능한 유일한 anti-BCMA 제제로 설명되며, 새로 간소화된 REMS 하에 이용 가능할 것입니다. DREAMM-7 및 DREAMM-8의 전체 생존 추적은 계속되며, 2028년 초에 데이터가 기대되며, 1차 치료 연구인 DREAMM-10의 3상 연구가 진행 중입니다.

GSK a annoncé l'approbation par la FDA américaine de Blenrep (belantamab mafodotin-blmf) en association avec le bortézomib et la dexaméthasone (BVd) chez des adultes atteints de myélome multiple en rémission ou résistant après au moins deux traitements préalables, dont un inhibiteur protéasome (PI) et un IMiD.

L'approbation est soutenue par l'essai de phase III DREAMM-7, où la combinaison BVd a réduit le risque de décès de 51% (HR 0,49 ; IC à 95% : 0,32–0,76) et a donné une survie sans progression médiane de 31,3 mois (IC à 95% : 23,5–NR) contre 10,4 mois (IC à 95% : 7,0–13,4) pour une trithérapie à base de daratumumab (HR 0,31 ; IC à 95% : 0,21–0,47). La sécurité était largement cohérente avec les profils connus.

Le Blenrep est décrit comme le seul agent anti-BCMA accessible en milieu communautaire et sera disponible sous un nouveau REMS simplifié. Le suivi de la survie globale dans DREAMM-7 et DREAMM-8 se poursuit, avec des données attendues début 2028, et l'étude de phase III DREAMM-10 en première ligne est en cours.

GSK hat die Zulassung der US-amerikanischen FDA für Blenrep (belantamab mafodotin-blmf) in Kombination mit Bortezomib und Dexamethason (BVd) bei Erwachsenen mit rezidivierendem oder refraktärem Multiplen Myelom nach mindestens zwei vorherigen Therapien, einschließlich eines PI und eines IMiD, angekündigt.

Die Zulassung wird durch den phase-III‑Trial DREAMM-7 gestützt, in dem die BVd-Kombination das Sterberisiko um 51% senkte (HR 0,49; 95% KI: 0,32–0,76) und eine mediale progressionsfreie Überlebensdauer von 31,3 Monaten (95% KI: 23,5–NR) gegenüber 10,4 Monaten (95% KI: 7,0–13,4) für eine daratumumab-basierte Dreierkombination erzielte (HR 0,31; 95% KI: 0,21–0,47). Die Sicherheit entsprach im Großen und Ganzen den bekannten Profilen.

Blenrep wird als einziger anti-BCMA-Wirkstoff beschrieben, der auch in Gemeinschaftseinrichtungen zugänglich ist, und wird unter einem neuen, schlankeren REMS verfügbar sein. Die Nachverfolgung des Gesamtüberlebens in DREAMM-7 und -8 läuft weiter, mit Daten, die Anfang 2028 erwartet werden, und die Phase-III-Studie DREAMM-10 in der Erstlinie befindet sich im Aufbau.

 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
Form 6-K
 
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
 
 
 
For the month of October 2025
 
Commission File Number 001-15170
 
 
GSK plc
(Translation of registrant's name into English)
 
 
79 New Oxford Street, London, WC1A 1DG
(Address of principal executive office)
 
 
 
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
 
Form 20-F . . . .X. . . . Form 40-F . . . . . . . .
  
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]
 
●     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]
 
●     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]
 
●     Robust clinical development is ongoing to advance Blenrep in earlier lines of treatment, including newly diagnosed patients[4]
 
 
 
 
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],[6]
 
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[7], UK[8], Japan[9], Canada, Switzerland and Brazil. Applications are currently under review in other markets globally, including China[10] 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],[12] There are approximately 180,000 new cases of multiple myeloma diagnosed globally each year.[13] Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.[14] 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],[16]
 
 
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[17].
 
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[18] 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[19] 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.
 
GSK enquiries
 
 
 
 
Media:
Simon Steel
+44 (0) 20 8047 5502
(London)
 
Madison Goring
+44 (0) 20 8047 5502
(London)
 
Kathleen Quinn
+1 202 603 5003
(Washington DC)
 
Lyndsay Meyer
+1 202 302 4595
(Washington DC)
 
 
 
 
Investor Relations:
Constantin Fest
+44 (0) 7831 826525
(London)
 
James Dodwell
+44 (0) 20 8047 2406
(London)
 
Mick Readey
+44 (0) 7990 339653
(London)
 
Steph Mountifield
+44 (0) 7796 707505
(London)
 
Sam Piper
+44 (0) 7824 525779
(London)
 
Jeff McLaughlin
+1 215 751 7002
(Philadelphia)
 
Frannie DeFranco
+1 215 751 3126
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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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[1] 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] Blenrep US Prescribing Information.
[3] Komodo claims data. Accessed 25 September 2025.
[4] 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] 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] 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] 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] 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] 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] 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] 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] 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] 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] 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] 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] 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] 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] 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] 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/.
 
 
SIGNATURES
 
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorised.
 
GSK plc
 
(Registrant)
 
 
Date: October 24, 2025
 
 
 
 
By:/s/ VICTORIA WHYTE
--------------------------
 
 
 
Victoria Whyte
 
Authorised Signatory for and on
 
behalf of GSK plc

Source: View Original Filing on SEC EDGAR

FAQ

What did GSK (GSK) announce regarding Blenrep?

The US FDA approved Blenrep with bortezomib and dexamethasone (BVd) for adults with relapsed/refractory multiple myeloma after at least two prior therapies.

What efficacy did Blenrep BVd show in DREAMM-7?

BVd cut the risk of death by 51% (HR 0.49) and achieved median PFS of 31.3 months versus 10.4 months for a daratumumab-based triplet.

Is Blenrep accessible in community settings?

Yes. It is described as the only anti-BCMA accessible across community settings and will be available under a new, streamlined REMS program.

What safety information is highlighted?

The safety and tolerability of the Blenrep combination were broadly consistent with the known profiles of the individual agents.

What future data milestones are noted for GSK (GSK)?

Follow-up for overall survival in DREAMM-7 and DREAMM-8 continues, with data expected in early 2028. The phase III DREAMM-10 first-line study is ongoing.

What is the approved indication for Blenrep BVd in the US?

Treatment of adults with relapsed or refractory multiple myeloma who received at least two prior lines, including a PI and an IMID.
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