GSK’s Blenrep gets green light in UK for relapsed myeloma

UK—GSK has received a major boost with the approval of its drug Blenrep (belantamab mafodotin) by the Medicines and Healthcare Products Regulatory Agency (MHRA) for use in adults with multiple myeloma, a type of blood cancer.

This marks the first global authorisation for Blenrep in this specific treatment setting, positioning the UK at the forefront of advancing care for patients with relapsed or refractory multiple myeloma.

Blenrep is now approved in the UK for use in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) for those who have previously received lenalidomide.

This means that patients who have already undergone standard treatments and experienced a relapse now have a new, potentially more effective option.

Results from two pivotal phase III clinical trials, DREAMM-7 and DREAMM-8, strongly supported the MHRA’s decision.

These studies demonstrated that Blenrep combinations provided statistically significant and clinically meaningful improvements in progression-free survival (PFS)—the duration for which patients lived without their disease worsening—compared to current standard-of-care treatments.

In the DREAMM-7 trial, for example, the Blenrep combination nearly tripled the median PFS to 36.6 months, compared to 13.4 months for the comparator regimen, and reduced the risk of death by 42%.

Additionally, the three-year overall survival rate was 74% for patients on the Blenrep combination, versus 60% for those on the standard treatment.

Safety data from these trials showed that the side effects of Blenrep combinations were generally manageable and consistent with what is already known about the individual drugs.

Eye-related side effects, a known risk with Blenrep, were typically resolved or managed by adjusting the dosing schedule, and led to treatment discontinuation in only a small percentage of cases.

Other common side effects included low platelet counts and diarrhea in DREAMM-7, and neutropenia, thrombocytopenia, and COVID-19 in DREAMM-8.

The approval is especially significant given the challenges faced by people with multiple myeloma. Most patients eventually experience relapse, and in the UK, only about 55% survive five years after diagnosis.

Blenrep stands out as the only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate available for multiple myeloma, offering a new mechanism of action for those who have exhausted other options.

Importantly, the treatment can be administered in a variety of healthcare settings without the need for complex preparation or hospitalisation, making it accessible to more patients.

GSK’s Hesham Abdullah, Senior Vice President and Global Head of Oncology R&D, called the approval a transformative milestone, noting that Blenrep can potentially extend patients’ survival and remission and redefine treatment strategies at or after first relapse.

Experts like Dr. Joseph Mikhael from the International Myeloma Foundation also highlighted the importance of new therapies with different mechanisms, especially as patients increasingly receive combination treatments from the outset.

Blenrep combinations are currently under review in 14 other countries, including the US, EU, and Japan, with further approvals expected in 2025.

This development underscores the urgent need for new, effective, and manageable therapies for multiple myeloma, a disease that remains incurable for most and affects over 180,000 people globally each year.

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