GSK announced the authorisation of Blenrep by the Medicines and Healthcare products Regulatory Agency (MHRA). In the UK, Blenrep is approved for the treatment of adults with multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide. This UK regulatory authorisation marks the first in the world for Blenrep in this treatment setting.

Superior efficacy results from the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple myeloma support MHRA authorisation of Blenrep combinations. These include statistically significant and clinically meaningful progression-free survival (PFS) results for Blenrep combinations versus standards of care in both trials and overall survival (OS) in DREAMM-7. The safety and tolerability profiles of the Blenrep combinations were broadly consistent with the known profiles of the individual agents.

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “Today's approval of Blenrep combinations in the UK is a transformative milestone for patients with multiple myeloma, a cancer marked by remission and relapse. As the only BCMA-targeted ADC therapy, Blenrep has the potential, supported by robust phase III data, to extend survival and remission versus standard of care and redefine treatment at or after first relapse.”

Currently, most patients with multiple myeloma experience relapse, and in the UK only 55% remain alive five years after diagnosis.5 Blenrep is the only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC) in multiple myeloma, providing patients at or after relapse with a differentiated mechanism of action. Blenrep combinations can be administered to a range of patient types in any oncology treatment setting without complex pre-administration regimens or hospitalisation.

Joseph Mikhael, MD, Chief Medical Officer, International Myeloma Foundation and Professor, Translational Genomics Research Institute, City of Hope Cancer Center, said: “As patients with multiple myeloma increasingly receive combination therapies at diagnosis, treatment options available in the community setting that use different mechanisms like Blenrep are crucial to extending remission and ultimately survival. We are pleased to see this advancement in the treatment landscape extended across both academic and community settings where many patients are treated.”