GSK’s Blenrep secures UK approval for multiple myeloma treatment​

UK — GSK has achieved a significant regulatory victory with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granting approval for Blenrep (belantamab mafodotin) in combination therapies for relapsed or refractory multiple myeloma (RRMM).

This marks the first global authorization for Blenrep in this new treatment setting, signaling a promising development for patients battling this challenging blood cancer. ​

Initially approved in 2020, Blenrep faced setbacks following the DREAMM-3 trial, which failed to demonstrate sufficient efficacy, leading to its withdrawal from the U.S. market in 2022.

However, GSK’s commitment to advancing treatment options led to further research and development, culminating in the recent MHRA approval. ​

The MHRA’s decision is underpinned by robust data from two pivotal Phase III trials: DREAMM-7 and DREAMM-8.

In the DREAMM-7 study, Blenrep combined with bortezomib and dexamethasone (BVd) significantly improved progression-free survival (PFS) to 36.6 months compared to 13.4 months with the standard daratumumab-based regimen.

Similarly, the DREAMM-8 trial demonstrated that Blenrep with pomalidomide and dexamethasone (BPd) reduced the risk of disease progression or death by 48% compared to the standard of care.

A new standard in treatment

Blenrep is now approved in the UK for use in combination with BVd for patients who have received at least one prior therapy, and with BPd for those who have received at least one prior therapy, including lenalidomide.

As the only BCMA-targeted antibody-drug conjugate (ADC) therapy approved in this setting, Blenrep offers a novel mechanism of action, potentially providing a more accessible alternative to complex treatments like CAR-T cell therapies. ​

GSK has submitted Blenrep for regulatory review in 14 additional countries, including the United States, where a decision is anticipated by July 23, 2025.

The company projects that Blenrep could achieve peak annual sales exceeding £3 billion, reinforcing its strategic focus on oncology and its commitment to delivering innovative treatments to patients worldwide. ​