Ella Day | May 21, 2025 | News story | Market Access, Research and Development, Sales and Marketing | GSK, Japan, Oncology, Orphan Drug Designation (ODD), multiple myeloma
GSK’s Blenrep (belantamab mafodotin) combinations have been approved by Japan’s Ministry of Health, Labour and Welfare for the treatment of adults with relapsed or refractory multiple myeloma. The treatment is currently under review in global markets, advancing its administration to patients worldwide.
The approval is grounded by results from the DREAMM-7 and DREAMM-8 phase 3 trials in relapsed or refractory multiple myeloma. The trials evaluated Blenrep in combination with bortezomib plus dexamethasone and in combination with pomalidomide plus dexamethasone, respectively, in patients with multiple myeloma who have received at least one prior therapy. Both demonstrated significant progression-free survival results for Blenrep combinations versus standards of care, in addition to excellent safety and tolerability results.
Blenrep is the only anti B-cell maturation antigen antibody-drug conjugate (ADC) approved in multiple myeloma, providing patients at or after relapse with an alternative treatment. Most patients with multiple myeloma relapse and, in Japan, only 43% survive five years post-diagnosis, highlighting the need for alternative treatment.
“Patients need additional treatment options at or after first relapse that can extend remission and survival,” commented Hesham Abdullah, global head of oncology at GSK. “Blenrep combinations have the potential to redefine treatment outcomes.”
The approval follows an Orphan Drug Designation for Blenrep in Japan. Moreover, it follows the first authorisation globally last month by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Blenrep combinations are under review globally, including in the US, EU, China, Canada and Switzerland.
Ella Day
21/5/25
AloJapan.com