On October 23, 2025, GlaxoSmithKline (GSK) announced that its Blenrep (belantamab mafodotin) medication had received FDA approval for the treatment of adult patients with relapsed or refractory multiple myeloma. Patients who have received at least two previous lines of therapy now have a new therapeutic option thanks to this approval.
The pivotal DREAMM-7 clinical trial’s findings served as the basis for the FDA’s decision. In comparison to a standard treatment regimen, the study showed that Blenrep tripled the median progression-free survival and significantly decreased the risk of death by 51%. For patients suffering from this difficult type of blood cancer, this ground-breaking result offers fresh hope.
Read More: GSK’s Blenrep Combinations Approved in Japan for Relapsed or Refractory Multiple Myeloma
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.
Tony Wood
More information is anticipated in early 2028 as GSK continues to investigate Blenrep’s potential in the early phases of multiple myeloma treatment. In the UK, Canada, Japan, and the European Union, the medication is already authorised for use; in other nations, regulatory reviews are still in progress. This broad approval demonstrates how Blenrep’s potential to enhance the quality of life for multiple myeloma patients is acknowledged worldwide.
Read More: European Medicines Agency Panel Recommends Blenrep Combinations for Multiple Myeloma
Pivotal Clinical Data from DREAMM-7 Trial
Blenrep in combination with bortezomib and dexamethasone (BVd) is the only medication approved by the FDA. Adult patients with RRMM who have undergone at least two previous lines of treatment, such as immunomodulatory (IMID) and proteasome inhibitor (PI), are eligible for this regimen.
The Phase III DREAMM-7 trial’s convincing findings, which contrasted the BVd combination with a daratumumab-based triplet (DVd), provided support for the decision. The trial’s main conclusions include:
- Overall Survival (OS): A clinically significant 51% decrease in the risk of death was shown by the Blenrep combination (Hazard Ratio [HR] 0.49).
- Progression-Free Survival (PFS): The Blenrep combination resulted in a tripled median PFS, rising from 10.4 months for the standard of care regimen to 31.3 months (HR 0.31).
- An important factor for long-term patient care is that the safety profile of the Blenrep combination was found to be largely in line with the profiles of the individual agents.
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Mechanism of Action and Accessibility
One of the first antibody-drug conjugates (ADCs) is Blenrep. It targets a protein that is highly expressed on multiple myeloma cells called B-cell maturation antigen (BCMA). Auristatin F, a cytotoxic agent that is administered directly to the cancer cell, is linked to a monoclonal antibody that targets BCMA in order for the medication to function.
GSK collaborated with the FDA to establish a new, simplified Risk Evaluation and Mitigation Strategy (REMS) program that would simplify administration and guarantee appropriate use and patient safety. By using streamlined patient forms and enhancing communication between ophthalmologists and healthcare providers (HCPs), who keep an eye out for the medication’s known ocular side effects, the new REMS lessens administrative burden.
Future Development and Disease Context
Generally regarded as treatable but incurable, multiple myeloma is the third most prevalent blood cancer in the world. Since the disease frequently becomes resistant to existing treatments, resulting in a cycle of relapse, research into new therapies is essential.
Through its comprehensive DREAMM clinical program, GSK is actively investigating the drug’s potential in previous treatment lines:
- DREAMM-8: The study’s overall survival is still being monitored, and data is anticipated in early 2028.
- DREAMM-10: This Phase III study was started in Q4 2024 and involves newly diagnosed, transplant-ineligible patients, who make up more than 70% of those beginning treatment. Early in 2028, interim safety and efficacy data are anticipated.
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Graduated from the University of Kerala with B.Sc. Botany and Biotechnology. Attained Post-Graduation in Biotechnology from the Kerala University of Fisheries and Ocean Science (KUFOS) with the third rank. Conducted various seminars and attended major Science conferences. Done 6 months of internship in ICMR – National Institute of Nutrition, Hyderabad. 5 years of tutoring experience.
