MHRA Approves GSK Therapy Combinations for Multiple Myeloma

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GSK announced on April 17, 2025 that its belantamab mafodotin, an antibody-drug conjugate (ADC) that comprises a humanized B cell maturation antigen (BCMA) monoclonal antibody (mAb) conjugated to the cytotoxic agent auristatin F via a non-cleavable linker, has been authorized by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) (1).

Belantamab mafodotin, under the brand name Blenrep, is approved in the UK for treatment of adults with multiple myeloma in either of two combinations: with bortezomib plus dexamethasone (BVd) for patients who have received at least one prior therapy, and with pomalidomide plus dexamethasone (BPd) for those who have received a prior therapy including lenalidomide (1).

“Today's approval of Blenrep combinations in the UK is a transformative milestone for patients with multiple myeloma, a cancer marked by remission and relapse,” Hesham Abdullah, senior vice president and global head Oncology, R&D, GSK, said in a company press release (1). “As the only BCMA-targeted ADC therapy, Blenrep has the potential, supported by robust Phase III data, to extend survival and remission versus standard of care and redefine treatment at or after first relapse.”

Two Phase III trials (DREAMM-7 and DREAMM-8) in relapsed or refractory multiple myeloma demonstrated superior efficacy results, according to GSK (1). Most patients with multiple myeloma experience relapse, with only 55% in the UK remaining alive five years after diagnosis.

“As patients with multiple myeloma increasingly receive combination therapies at diagnosis, treatment options available in the community setting that use different mechanisms like Blenrep are crucial to extending remission and ultimately survival,” Joseph Mikhael, MD, chief medical officer of the International Myeloma Foundation and professor at the Translational Genomics Research Institute, City of Hope Cancer Center, said in the GSK release (1). “We are pleased to see this advancement in the treatment landscape extended across both academic and community settings where many patients are treated.”

In Europe, GSK’s belantamab mafodotin therapy has cleared several hurdles in the previous two years. At the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) October 2023 meeting, a re-examination of EMA’s September 2023 opinion of Blenrep was requested, after which EMA said it would review and make final recommendations (2). An acceptance of GSK’s marketing authorization application then came in July 2024, for belantamab mafodotin in combination with BVd (also known as BorDex) or BPd (also known as PomDex), at which point EMA said CHMP would launch a formal review to make a recommendation to the European Commission (3).

The latest movement on Blenrep in the United States was in November 2024, when FDA accepted the Biologics License Application for belantamab mafodotin, in the same combinations as above (4). The combinations have a Prescription Drug User Fee Act date of July 23, 2025 (1).

GSK said belantamab mafodotin combinations are also currently under review in Japan, China, Canada, and Switzerland (1).

References

1. GSK. Blenrep (belantamab mafodotin) Combinations Approved by UK MHRA in Relapsed/Refractory Multiple Myeloma. Press Release. April 21, 2025.
2. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 9–12 October 2023. Press Release. Oct. 13, 2023.
3. GSK. Blenrep (belantamab mafodotin) Combinations in Multiple Myeloma Application Accepted for Review by the European Medicines Agency. Press Release. July 19, 2024.
4. GSK. Blenrep Combinations Accepted for Review by the US FDA for the Treatment of Relapsed/Refractory Multiple Myeloma. Press Release, Nov. 25, 2024.