MHRA Approves GSK's Blenrep for Multiple Myeloma

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval to GSK’s Blenrep for the treatment of adults with multiple myeloma, marking a pioneering global endorsement for this indication. This new authorization allows Blenrep, when used in combination with bortezomib and dexamethasone (BVd), to treat patients who have previously undergone at least one treatment regimen. Additionally, it is cleared for use alongside pomalidomide and dexamethasone (BPd) for those who have been treated with lenalidomide and other therapies.

The MHRA's decision is backed by significant efficacy results from the Phase III DREAMM-7 and DREAMM-8 clinical trials, which demonstrated notable improvements in progression-free survival (PFS) and overall survival (OS) for patients with relapsed or refractory multiple myeloma. The safety and tolerability profiles of Blenrep, when used in these combinations, are consistent with the effects observed with the individual agents.

Currently, Blenrep combination therapies are under review in 14 nations, including key markets such as the United States, Japan, the European Union, China, Switzerland, and Canada, reflecting its potential global impact on multiple myeloma treatment strategies.

Hesham Abdullah, GSK's oncology research and development global head and senior vice-president, expressed optimism about the approval, describing it as a significant advancement for multiple myeloma patients. He noted that because Blenrep is the only B-cell maturation antigen (BCMA)-targeted antibody-drug conjugate (ADC) therapy available, it presents an opportunity to enhance survival and remission compared to standard treatment approaches, based on strong phase III trial data.

Blenrep is composed of an ADC that combines a humanized antibody specifically targeting BCMA with the cytotoxic agent auristatin F, connected through a stable linker. This drug-linker technology is licensed from Seagen, and the production of the monoclonal antibody utilizes the POTELLIGENT Technology, which is licensed from Kyowa Kirin Group’s BioWa. As the sole anti-BCMA ADC approved for multiple myeloma, Blenrep holds promise for broader application across various oncology treatment settings.

In addition to its advancements in oncology, GSK is exploring opportunities in the field of dementia research. Recently, the company has partnered with the UK Dementia Research Institute (UK DRI) and Health Data Research UK (HDR UK) to investigate whether its shingles vaccine, Shingrix, could potentially reduce the risk of developing dementia. This collaboration underscores GSK’s commitment to leveraging its resources and expertise to address significant health challenges beyond oncology.