Belantamab was re-approved for marketing in the UK, and combination therapy significantly prolonged the survival of patients with multiple myeloma

In April 2025, GlaxoSmithKline (GSK) announced that it had developed Antibody-Drug conjugate (ADC) - Belantamab (Belantamab Mafodotin, trade name Blenrep) has successfully obtained marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA). This approval will provide a new treatment option for patients with multiple myeloma who have received at least one prior therapy, especially those whose disease has progressed after first-line therapy.

This timeMHRAapprovedBlenrep for use in combination with two different regimens: one is with bortezomib (bortezomib) and dexamethasone (< /span>dexamethasone) combination therapy is used for patients who have received at least one treatment; the second is combined use with pomalidomide (pomalidomide) and dexamethasone, which is suitable for patients who have previously received treatment regimens such as lenalidomide. It is worth noting that this is the first time in the world that a country has officially approved Blenrep for use in such a therapeutic setting. Currently, this joint program is also undergoing regulatory review in many countries and regions, including the United States, the European Union, China, Japan, Canada and Switzerland.

Blenrepis an ADC drug that targets B cell maturation antigen (BCMA). Its working mechanism is different from traditional treatment options. By conjugating monoclonal antibodies with cytotoxic drugs, Blenrep can accurately identify and kill BCMA-expressing myeloma cells, thereby exerting anti-tumor effects without relying on hospitalization or complex conditioning regimens. The drug had been approved in many countries as a third-line and above treatment option before, but it was voluntarily withdrawn from the market in 2023 because the confirmatory trial did not meet expectations. Now, with a new round of clinical trial data proving its significant effect in people with early relapse, Blenrep has once again made breakthrough progress.

The basis for the new approval comes from two pivotal III clinical studies - DREAMM-7 and DREAMM-8 . These two trials respectively verified the efficacy of Blenrep and different combination drugs in relapsed or refractory multiple myeloma. DREAMM-7In the study, the treatment group of Blenrep combined with bortezomib and dexamethasone showed obvious advantages, and its median progression-free survival (PFS) reached 36.6 months, almost twice that of the control group daratumumab combination (13.4 months), and the risk of death was reduced by 42%, and the three-year survival rate was improved from 60% to 74%.

In the DREAMM-8 trial, researchers combined Blenrep with pomalidomide and dexamethasone and compared it with bortezomib. At a median follow-up of nearly 22 months, the Blenrep combination group has not yet reached median PF S, which generally represents more durable disease control, compared with the median PFSin the control group of 12.7 months. Both studies showed that the safety profile of the Blenrep combination is basically consistent with its previously known adverse reactions, and no new serious safety issues were observed, indicating that it is well tolerated and suitable for long-term treatment.

With this re-launch in the UK, Blenrep not only provides innovative options for the treatment of multiple myeloma, but also marks that the important position of BCMA targeted therapy in the field of myeloma treatment is constantly strengthening. In the future, as approval results are released in more countries, this therapy is expected to benefit patients around the world more broadly.

References:BLENREP (belantamab mafodotin) combinations approved by UK MHRA in relapsed/refractory multiple myeloma’, press release. GSK plc; published 17 April 2025.