Belantamab Mafodotin Combinations Approved in Japan for Relapsed or Refractory Myeloma

Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved belantamab mafodotin (Blenrep) in combination with other agents for the treatment of relapsed or refractory multiple myeloma, according to a press release from GSK.¹

The approval is based on data from the phase 3 DREAMM-7 and DREAMM-8 trials, which evaluated belantamab mafodotin in combination with bortezomib plus dexamethasone (BVd) and in combination with pomalidomide plus dexamethasone (BPd) for patients who received at least one prior line of therapy.¹

In the DREAMM-7 trial, BVd showed a superior progression-free survival (PFS) benefit compared with daratumumab, bortezomib, and dexamethasone (DVd; 36.6 months vs 13.4 months, respectively) at a median follow-up of 28.2 months. Ninety-five percent of patients in the BVd group and 78% of patients in the DVd group experienced grade 3 or higher adverse events. Ocular events occurred in 79% of patients in the BVd group and 29% of patients in the DVd group and were managed with dose modifications.²

In DREAMM-8, BPd showed a superior 12-month estimated PFS compared with pomalidomide, bortezomib, and dexamethasone (PVd; 71% vs 51%, respectively) at a median follow-up of 21.8 months. Ninety-four percent of patients in the BPd group and 76% of patients in the PVd group experienced grade 3 or higher adverse events. Ocular events occurred in 89% of patients in the BPd group and 30% of patients in the PVd group and were also managed with dose modification.³

“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,” said Hesham Abdullah, MD, senior vice president, global head of Oncology, Research and Development at GSK, in the press release.¹

A Biologics License Application for belantamab mafodotin in combination with BVd and BPd was previously accepted for review by the FDA in November 2024, with a decision expected in July 2025.⁴

Read more: DREAMM-7 Data Show Belamaf Triplet Is Superior to Daratumumab Triplet in Myeloma