HQ Team
April 18, 2025: Britain’s Medicines and Healthcare products Regulatory Agency has authorised GSK Plc’s combination drug to treat patients with multiple myeloma who have received at least one prior therapy.
Multiple myeloma is a rare blood cancer that occurs when plasma cells in the bone marrow become cancerous and multiply out of control. The cancerous cells produce abnormal antibodies that damage bones, kidneys, and the ability to make healthy blood cells.
The drug Blenrep has been approved for treatment in combination with bortezomib plus dexamethasone in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone in patients who have received at least one prior therapy, including lenalidomide.
Efficacy results from two end-trials in relapsed or refractory multiple myeloma support MHRA authorisation of Blenrep combinations, according to a GSK statement.
Delay progression
“These include statistically significant and clinically meaningful progression-free survival results for Blenrep combinations versus standards of care in both trials and overall survival,” during the trials.
In progression-free survival (PFS), if a treatment is effective, it will delay the progression of the disease, so the patient experiences a longer period without worsening symptoms or tumour growth.
PFS is often used as a measure in clinical trials because it can be observed sooner than overall survival (OS), which is the time until death from any cause. OS can take a long time to measure, especially if patients live for many years after treatment.
The safety and tolerability profiles of Blenrep combinations were broadly consistent with the known profiles of the individual agents, according to the statement.
‘Remission and relapse’
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.”
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, he said.
Currently, most patients with multiple myeloma experience relapse, and in the UK, only 55% remain alive five years after diagnosis. The UK is the first country to approve the combination drug’s treatment.
The combination drug is the only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate in multiple myeloma, providing patients at or after relapse with a new mechanism of action.
No hospitalisation
The combinations can be administered to many patients in any oncology treatment without complex pre-administration regimens or hospitalisation, according to the statement.
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.”
Blenrep combinations are currently under review in 14 countries, including the US with a Prescription Drug User Fee Act (PDUFA) date of 23 July 2025, European Union, Japan (with priority review) and China.
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable. There are more than 180,000 new cases of multiple myeloma diagnosed globally each year.
Multiple myeloma is a significant concern in the UK, which ranks fifth in incidence rate among all European countries. There are about 6,500 new cases of multiple myeloma diagnosed each year, and an expected five-year prevalence of over 19,400 cases in the UK.
The technology is licensed from Seagen Inc., and the monoclonal antibody is produced using technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.
