UK approval brings GSK's Blenrep back from the brink

Title

GSK’s Blenrep Wins UK Approval for Multiple Myeloma Comeback Following Positive Phase III Results

Keywords

Blenrep
belantamab mafodotin
GSK
multiple myeloma
antibody-drug conjugate (ADC)
UK MHRA approval
DREAMM-7 trial
DREAMM-8 trial
bortezomib
pomalidomide
dexamethasone
BCMA-targeted therapy
relapsed/refractory myeloma
oncology drug approval

Key Facts

Blenrep (belantamab mafodotin), an antibody-drug conjugate targeting BCMA, has been re-approved in the UK for the treatment of adult patients with multiple myeloma in combination with either bortezomib plus dexamethasone or pomalidomide plus dexamethasone, after at least one prior therapy2 4 5.
This marks the world’s first regulatory approval for Blenrep since its global withdrawal in 2022, which followed disappointing results in a confirmatory monotherapy trial (DREAMM-3)1 2 5 6.
The new approval is underpinned by robust phase III data from the DREAMM-7 and DREAMM-8 trials, which demonstrated statistically significant and clinically meaningful improvements in progression-free survival and overall survival for Blenrep combos versus standard of care2 4 7 10.
In DREAMM-7, Blenrep plus bortezomib and dexamethasone (BVd) reduced the risk of disease progression or death by 59% compared with Darzalex-based regimens, and decreased the risk of death by 42%2 4 7 8.
In DREAMM-8, Blenrep plus pomalidomide and dexamethasone (BPd) cut the risk of progression or death by 48% versus the standard of care triplet2 4 10.
Blenrep’s safety profile in these combinations was consistent with known side effects, with ocular toxicity (eye-related side effects) remaining a notable concern, but was manageable in the context of improved efficacy7 10.
GSK aims for Blenrep to become a new standard of care at or after first relapse and projects peak annual sales potentially topping £3 billion ($4 billion), supporting an ambitious sales target for the company’s oncology portfolio2.
The UK approval is expected to lead to regulatory decisions in 14 additional countries, including a US FDA verdict anticipated by July 23, 20252 5 9.
Blenrep stands out for its off-the-shelf convenience compared to CAR-T therapies, which require complex manufacturing from the patient’s own cells2.
Multiple myeloma remains incurable and characterized by eventual relapse; in the UK, only 55% of patients survive five years post-diagnosis, highlighting the need for new, effective treatment options4.