GSK has announced the approval of Blenrep (belantamab mafodotin) combinations by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of relapsed or refractory multiple myeloma.
In the UK, Blenrep can now be used in combination with bortezomib and dexamethasone (BVd) for adults who have received at least one previous therapy. It is also approved in combination with pomalidomide and dexamethasone (BPd) for patients who have had at least one prior therapy, including lenalidomide.
This marks the first global authorisation of Blenrep in this treatment setting.
GSK senior vice president and oncology research and development global head Hesham Abdullah 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.”
The MHRA’s decision was supported by data from the DREAMM-7 and DREAMM-8 phase III trials. These trials demonstrated that Blenrep combinations achieved statistically significant improvements in progression-free survival compared to standard care.
In the DREAMM-7 trial, Blenrep nearly tripled median progression-free survival compared to a daratumumab-based regimen. The trial also indicated a significant reduction in mortality risk with a 42% decrease in the chance of death at a median follow-up of 39.4 months.
In the DREAMM-8 trial, while the median progression-free survival had not yet been reached at a median follow-up of 21.8 months, it showed promising results over the bortezomib combination.
The trials indicated that Blenrep combinations effectively served various patient groups, including those with high-risk factors or those refractory to lenalidomide. Improvements were observed in secondary efficacy endpoints across all comparator groups.
Currently, Blenrep combinations are under review in 14 countries, including the US, where a US Food and Drug Administration (FDA) decision is expected by July 2025.
Blenrep is an antibody-drug conjugate (ADC) comprising a humanised BCMA monoclonal antibody linked to auristatin F, a cytotoxic agent. This drug employs technology licensed from Seagen and BioWa, part of the Kyowa Kirin Group.
In another development, Health Canada has broadened its approval for GSK’s Jemperli (dostarlimab for injection), allowing its use alongside chemotherapy for adults with primary advanced or first recurrent endometrial cancer.
This extension includes patients with mismatch repair proficient/microsatellite stable tumours, accounting for approximately 75% of cases in this category.
