GSK announces approval of Blenrep combinations by Japan’s MHLW

GSK (GSK) announced the approval of Blenrep combinations by Japan’s Ministry of Health, Labour and Welfare, MHLW, for the treatment of adults with relapsed or refractory multiple myeloma. The approval is based on positive results from the DREAMM-7 and DREAMM-8 phase III trials evaluating 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. The approval follows an orphan drug designation for Blenrep in Japan, which was granted based on its ability to address high unmet need for patients with multiple myeloma. Superior efficacy results from the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple myeloma support MHLW approval of Blenrep combinations. These include statistically significant and clinically meaningful progression-free survival results for Blenrep combinations versus standards of care in both trials and overall survival in DREAMM-7. The safety and tolerability profiles of the Blenrep combinations were broadly consistent with the known profiles of the individual agents.