Blenrep's Return in the UK: Why it Matters for All Myeloma Patients

Blenrep (belantamab mafodotin, GSK), a BCMA-targeting antibody drug conjugate, was just approved for treatment in relapsed and refractory myeloma in the United Kingdom. Global approvals are anticipated later in 2025 as this treatment is reinstated as a viable treatment option for relapsed myeloma patients.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved the therapy and is the equivalent agency of the FDA in the United States. 

Why the Approval Matters Globally

The MHRA’s approval is the first global re-approval of Blenrep. The treatment is approved for patients who have received one prior line of therapy in combination with bortezomib and dexamethasone (Bad), or pomalidomide and dexamethasone (BPd), providing additional therapy options earlier in a myeloma patient’s journey.

Blenrep encountered a significant setback when it was withdrawn from the market in February of 2023. The reason for the withdrawal was not safety-related.

The FDA had provided Blenrep with accelerated approval based on future confirmatory trial data. When the DREAMM-3 study released its data, there was insufficient statistical significance showing that the Blenrep treatment arm was better.

Fortunately, two additional Phase III Blenrep clinical trials were already underway. The DREAMM-7 and DREAMM-8  trials have now both released positive data, showing superiority over today’s standard-of-care treatments.

In the DREAMM-7 study, the Blenrep combination (36.6 months) nearly tripled median progression-free survival (PFS) compared to a daratumumab-based regimen (13.4 months) with a 42% reduction in risk of death.

Similarly, in the DREAMM-8 study with over two years of follow-up, the median progression-free survival has not yet been reached - a positive signal for durable disease control.

Blenrep is currently under review in 14 additional countries, including the U.S., with a target decision date in July 2025.

Antibody Drug Conjugates: A New Drug Class in Multiple Myeloma

Antibody drug conjugates are commonly used in other cancers such as lymphomas, breast cancer, bladder cancer and many others. They combine a targeted monoclonal antibody with a toxic payload, enabling the immune system to more precisely search and destroy cancer cells. Blenrep targets BCMA (B-cell maturation antigen), which is a common target being used to treat myeloma with bispecific antibodies and CAR T-cell therapies.

Blenrep is unique when compared to other BCMA-targeted treatments because it does not rely on the health of the immune system to be effective.

An Accessible Therapy

Unlike some myeloma immunotherapies that need to be administered at an academic center, for safety reasons, Blenrep is easily available in community oncology clinics. While eye side effects like blurry vision were noted—a known issue with Blenrep—they were largely manageable through dose adjustments and did not lead to high discontinuation rates. This highlights the potential for safe, long-term treatment when managed appropriately.

What This Means for Myeloma Patients

Multiple myeloma remains an incurable cancer, with most patients experiencing multiple relapses over a lifetime. In the UK, for example, only 55% of patients are still alive five years after diagnosis.

This once dismissed treatment, now backed by compelling data, will provide relief to patients who are still waiting for curative strategies. We are hopeful that global regulatory agencies will follow suit. 

Continue Reading Myeloma News

Source: 

• Blenrep (belantamab mafodotin) combinations approved by UK MHRA in relapsed/refractory multiple myeloma