MHRA Approves GSK's Blenrep Combos for Multiple Myeloma

GSK's Blenrep (belantamab mafodotin) has recently gained approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for its use in treating multiple myeloma in adults. This approval signifies a significant development in the treatment options for this type of blood cancer, which arises in plasma cells located in the bone marrow. Each year, approximately 6,500 new cases of multiple myeloma are identified in the UK. Despite various treatments, a majority of patients experience disease recurrence, with only about 55% surviving five years post-diagnosis.

Blenrep stands out as the sole B-cell maturation antigen (BCMA)-targeted antibody-drug conjugate available for multiple myeloma. Its unique action mechanism sets it apart from other treatments. The drug is approved for use alongside bortezomib plus dexamethasone (BVd) for patients who have undergone at least one prior therapy. It is also approved in combination with pomalidomide plus dexamethasone (BPd) for those who have previously received treatment that included lenalidomide. Importantly, treatments involving Blenrep can be administered in any oncological setting without necessitating hospitalisation or intricate pre-treatment protocols.

The MHRA's authorisation of Blenrep in this new treatment context is a world first, supported by findings from phase 3 clinical trials, DREAMM-7 and DREAMM-8, involving patients with relapsed or refractory multiple myeloma. The results from these studies highlighted significant improvements in progression-free survival for patients receiving Blenrep combinations compared to those receiving standard triplet therapy combinations. Notably, the DREAMM-7 trial also achieved its secondary endpoint of overall survival, underscoring the efficacy of Blenrep.

Beyond progression-free survival, Blenrep demonstrated clinically significant enhancements in other secondary efficacy measures, showing deeper and more sustained responses. The safety and tolerability of Blenrep combinations were reported to align closely with what is already known about the individual agents' profiles. Hesham Abdullah, GSK's senior vice president and global head of oncology research and development, heralded the approval as a transformative step forward for multiple myeloma patients. He emphasized that, as the only BCMA-targeted antibody-drug conjugate therapy, Blenrep has the potential to prolong survival and remission compared to standard treatments, particularly at or following the first relapse.

The approval of Blenrep combinations is not just limited to the UK; they are under review in 14 other countries, including the United States and the European Union. In the US, a decision is anticipated by July 23, 2025, under the Prescription Drug User Fee Act. This broad international review underscores the significance of Blenrep as a promising option in the global battle against multiple myeloma, offering hope for improved patient outcomes and potentially redefining treatment paradigms.