Category: 3. Business

• Significant unmet need for patients requires new and novel treatments¹
• 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 triplet²
• Blenrep is the only anti-BCMA accessible in the community setting where 70% of patients receive care, and with a new streamlined REMS programme³
• Robust clinical development is ongoing to advance Blenrep in earlier lines of treatment, including newly diagnosed patients⁴

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 Union⁷, UK⁸, Japan⁹, Canada, Switzerland and Brazil. Applications are currently under review in other markets globally, including China¹⁰ 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.  Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.¹³ 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 here¹⁷.

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 results¹⁷ 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 results¹⁸ 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.

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.

References

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/.

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Ford has warned of a profit hit of up to $2bn from a fire at an aluminium supplier’s plant in New York, prompting a downgrade in its annual guidance.

The September 16 fire at the plant operated by Novelis has shut down production of aluminium sheets that are widely used by the car industry in the US, including by Ford and Stellantis. 

On Thursday, Ford said it expects an adjusted operating profit of $6bn-$6.5bn for the full year, compared with its earlier target range of $6.5bn-$7.5bn. The downgraded forecast included up to $1bn in net tariff impact, which was smaller than the $2bn net hit it projected in July.

Chief financial officer Sherry House said the company would have raised its guidance if not for the cost impact from the Novelis plant fire.

The carmaker said it would add 1,000 jobs across plants in Michigan and Kentucky to increase output of F-series trucks by more than 50,000 vehicles next year to recover production losses caused by the fire.

For the September quarter, Ford reported net income of $2.4bn on a 9 per cent increase in revenue to a record $50.5bn.

Ford’s adjusted earnings of $2.6bn before interest and tax was flat year-on-year, but higher than the average analyst estimate for $2bn, according to Visible Alpha. For the quarter, it booked a tariff impact of $700mn.

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Roula Khalaf, Editor of the FT, selects her favourite stories in this weekly newsletter.

Intel shares rose 6 per cent after the troubled chipmaker reported better than expected revenue, adding to its momentum following big investments from the Trump administration, Nvidia and Japan’s SoftBank.

The Santa Clara, California-based tech group reported revenue was $13.7bn, up 3 per cent year-on-year — beating Wall Street expectations of $13.1bn.

Intel expected revenue of between $12.8bn and $13.8bn for the fourth quarter, roughly in line with consensus estimates.

It said the trio of investments had strengthened its finances as it seeks to turn around its expensive effort to build advanced chip manufacturing in the US.

Chief financial officer David Zinsner said: “We took meaningful steps this quarter to strengthen our balance sheet, including accelerated funding from the US government and investments by Nvidia and SoftBank Group that increase our operational flexibility and demonstrate the critical role we play in the ecosystem.”

Intel also benefited from deals to sell stakes in specialist chip company Altera and automotive technology company Mobileye. Its upbeat guidance came despite losing income due to its smaller share of Altera.

It reported $4.3bn in net income, its first quarterly profit since 2023, following a record $17bn net loss a year ago resulting from restructuring and impairment charges.

Performance in Intel’s manufacturing business improved, with $4.2bn in revenue, as a result of greater efficiency in its chip foundries.

Personal computer chip sales, which have been relatively flat in recent quarters, also exceeded expectations, driven by upgrades to Microsoft’s operating system. It also cited a broader artificial intelligence-driven increase in demand for its PC and server products. 

Intel’s gross margin improved to 40 per cent during the quarter — boosted by a return to in-house manufacturing. Margins had been eroded by outsourcing Intel’s most advanced manufacturing to Taiwan’s TSMC.

Intel is also trying to win giant chip clients such as Apple, Qualcomm and Nvidia back from TSMC. The manufacturing push has led to billions in losses.

Some analysts had expected Intel to sell the manufacturing unit. But Lip-Bu Tan, who was appointed chief executive in March, has faced pressure from the Trump administration to continue the US chipmaking push and has committed to holding the company together.

Intel shares had risen about 85 per in the six months leading up to Thursday’s earnings report. Investor confidence was boosted by the US government converting manufacturing grants into a 10 per cent equity stake in the company, which was followed by SoftBank buying $2bn in shares and Nvidia agreeing to a chip partnership and a $5bn investment.

But the influx of cash has not resolved Intel’s long-term problems. Ahead of Thursday’s announcement, Bernstein analysts said the company’s position was “still precarious”, with continued uncertainty about the future of its manufacturing business and ongoing losses in its core chip business, leading to a “very stretchy valuation”.

Intel also disclosed the extent of recent job cuts, saying it had shed almost 30 per cent of its staff in a year, as Tan seeks to cut out middle management layers he says have slowed its innovation.

—Insmed Leads Science Top Employers List for Fifth Year in a Row—

BRIDGEWATER, N.J., Oct. 23, 2025 /PRNewswire/ — Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that it has earned the highest ranking in Science‘s 2025 Top Employers Survey. The annual survey polls employees in biotechnology, pharmaceutical, and related industries to determine the companies with the best reputations as employers.

“It is an incredible privilege to see our organization recognized as the top employer in Science’s annual survey for a record five consecutive years—something only achieved once before when the list first began,” said Will Lewis, Chair and Chief Executive Officer of Insmed. “We are experiencing an extraordinary period of growth, driven by a series of clinical successes and regulatory milestones that support us in working toward our mission to transform the lives of patients with serious and rare diseases. This recognition reflects not only our deep commitment to advancing science, but also the passion and purpose that drive our work every day.”

The 2025 survey results were based on approximately 5,500 responses from individuals located primarily across North America (66%), Europe (20%), and Asia/Pacific Rim (9%). This year’s highest-ranking companies stood out in the areas of corporate image, financial prowess, leadership and direction, work culture and environment, and academic and intellectual challenge.

“Being recognized once again by Science as the top employer in the biopharma industry is a tremendous honor and a reflection of the people-first culture we continue to build at Insmed,” said Nicole Schaeffer, Chief People Strategy Officer of Insmed. “By fostering an environment where collaboration meets flexibility, we enable our talented team to drive scientific breakthroughs on behalf of patients with serious diseases. I’m grateful to every colleague who makes Insmed such a special place to work.”

The complete feature and company rankings can be accessed here. To learn more about Insmed’s culture, please visit  https://insmed.com/company/culture/.

About Insmed

Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed’s most advanced programs are in pulmonary and inflammatory conditions, including two approved therapies to treat chronic, debilitating lung diseases. The Company’s early-stage programs encompass a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue.

Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 Science Top Employer. Visit www.insmed.com to learn more or follow us on LinkedIn, Instagram, YouTube, and X.

Contact:

Investors:

Bryan Dunn
Vice President, Investor Relations
(646) 812-4030
[email protected] 

Media:

Claire Mulhearn
Vice President, Corporate Communications
(862) 842-6819
[email protected]        

SOURCE Insmed Incorporated