GSK has secured approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for the use of Blenrep (belantamab mafodotin) in combination therapies to treat adults with relapsed or refractory multiple myeloma.
This decision follows the positive outcomes of the DREAMM-7 and DREAMM-8 Phase III clinical trials. These trials evaluated Blenrep with bortezomib plus dexamethasone (BVd) and pomalidomide plus dexamethasone (BPd) in patients who had undergone at least one previous therapy.
The approval was also influenced by Blenrep’s orphan drug designation in Japan, recognising its potential to meet the significant unmet needs of multiple myeloma patients.
GSK senior vice president and oncology, research and development global head Hesham Abdullah said: “Today’s approval brings the benefits of Blenrep combinations to patients with relapsed or refractory multiple myeloma in Japan. Patients need additional treatment options at or after first relapse that can extend remission and survival versus standard of care.
“Blenrep combinations have the potential to redefine treatment outcomes based on superior efficacy shown in two phase III trials, with the added advantage of in-office administration in both academic and community treatment settings.”
The DREAMM-7 and DREAMM-8 trials demonstrated superior efficacy for Blenrep combinations, highlighting significant progression-free survival compared to standard treatments and overall survival in the DREAMM-7 study.
Safety and tolerability for these combinations remained consistent with the profiles of each individual drug used. In Japan, approximately 57% of multiple myeloma patients do not survive beyond five years after diagnosis, prompting the need for effective treatments like Blenrep.
As the only anti-BCMA antibody-drug conjugate approved for multiple myeloma, Blenrep offers a unique mechanism of action, suitable for various patient types without requiring complex pre-administration regimens.
The clinical trials showcased the benefits of Blenrep combinations across a spectrum of patients, including those with adverse prognostic indicators such as high-risk cytogenetics or lenalidomide-refractory conditions.
Significant improvements were observed in secondary efficacy endpoints, delivering deeper and more enduring responses compared to alternative treatment options. Side effects related to the eyes were managed through extended infusion intervals and dose reductions, maintaining patient benefits and resulting in low discontinuation rates.
Eye-related issues resolved in 83% of cases, with ongoing monitoring for others. No permanent bilateral vision loss has been reported in ongoing trials or previous monotherapy experiences.
Common non-ocular adverse events included thrombocytopenia and diarrhoea in DREAMM-7, and neutropenia, thrombocytopenia, and COVID-19 in DREAMM-8.
This marks the second significant regulatory approval for Blenrep combinations in the treatment of relapsed or refractory multiple myeloma, following a similar authorisation by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
Blenrep combinations are under review in major markets worldwide, including the US, with a Prescription Drug User Fee Act (PDUFA) date set for July 2025, the European Union, China, Canada, and Switzerland, with particular attention to findings from the DREAMM-7 and DREAMM-8 trials.
Blenrep is an antibody-drug conjugate comprising a humanised BCMA monoclonal antibody linked to the cytotoxic agent auristatin F. The linker technology is licensed from Seagen, while the monoclonal antibody is developed using POTELLIGENT Technology, licensed from BioWa, a Kyowa Kirin Group member.
