UK MHRA Approves Blenrep Combos for Relapsed/Refractory Multiple Myeloma

LONDON, UK I April 17, 2025 I GSK plc (LSE/NYSE: GSK) announced that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Blenrep for treating adults with multiple myeloma. This approval allows Blenrep to be used in combination with bortezomib plus dexamethasone (BVd) for patients who have undergone at least one prior therapy, and with pomalidomide plus dexamethasone (BPd) for those who have previously received lenalidomide. This regulatory authorisation is the first of its kind globally for Blenrep in this treatment context.

The authorisation by MHRA is supported by the superior efficacy demonstrated in the DREAMM-7 and DREAMM-8 phase III trials, which involved patients with relapsed or refractory multiple myeloma. These studies showed statistically significant and clinically relevant improvements in progression-free survival (PFS) when using Blenrep combinations compared to traditional care options. Notably, the DREAMM-7 trial also showed enhanced overall survival (OS) metrics.

The safety and tolerability of Blenrep combinations align with the known profiles of the individual drugs used in the regimen. Hesham Abdullah, GSK's Senior Vice President and Global Head of Oncology R&D, highlighted that the approval of Blenrep marks a transformative step for multiple myeloma patients, a disease often characterized by cycles of remission and relapse. Blenrep, as the only BCMA-targeted antibody-drug conjugate (ADC) therapy, is poised to improve survival rates and redefine treatment strategies for patients experiencing a relapse.

In the UK, approximately 55% of multiple myeloma patients survive five years post-diagnosis. Blenrep stands out as the only anti-BCMA ADC available to patients who have relapsed, offering a unique mechanism of action. It can be administered to various patient types across oncology settings without needing complex pre-treatment procedures or hospital stays.

Joseph Mikhael, MD, Chief Medical Officer of the International Myeloma Foundation, emphasized the significance of having diverse treatment options like Blenrep in community settings. These options are crucial as more patients receive combination therapies upon diagnosis, which can extend remission periods and ultimately enhance survival rates.

The DREAMM-7 trial revealed that the Blenrep combination nearly tripled median PFS compared to a daratumumab-based comparator (36.6 months vs. 13.4 months). It also reached a key secondary endpoint of OS, with a notable 42% reduction in the risk of death after a median follow-up of 39.4 months. Additionally, the three-year OS rate was superior in the Blenrep group (74%) compared to the daratumumab group (60%). In the DREAMM-8 study, the Blenrep combination showed PFS benefits at a median follow-up of 21.8 months, outperforming the bortezomib combination where median PFS hadn’t been reached.

Blenrep's efficacy was evident across various patient demographics, including those with poor prognostic markers like high-risk cytogenetics or resistance to lenalidomide. Both trials demonstrated substantial improvements in secondary efficacy outcomes, such as deeper and more sustained responses compared to their comparators.

Ocular side effects, a known risk with Blenrep, were generally manageable, and extended intervals between treatments and dose adjustments helped maintain effectiveness. These side effects led to low treatment discontinuation rates (≤9%) in the studies. Commonly reported non-ocular adverse events included thrombocytopenia and diarrhoea in the DREAMM-7 trial, and neutropenia, thrombocytopenia, and COVID-19 in DREAMM-8.

Blenrep combinations are pending review in 14 countries, including the US, European Union, Japan, China, Canada, and Switzerland, with some regions granting priority reviews based on the promising results of the DREAMM-7 and DREAMM-8 trials.