British drug maker GSK plc (GSK.L, GSK) announced Monday the approval of Blenrep combinations by Japan's Ministry of Health, Labour and Welfare or MHLW for the treatment of adults with relapsed or refractory multiple myeloma.
The approval follows superior efficacy shown in two head-to-head phase III trials, including overall survival in DREAMM-7. The company noted that it is the second major approval for Blenrep combinations, with more expected in 2025. The first authorisation in the world was by the UK Medicines and Healthcare products Regulatory Agency (MHRA) last month.
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.
The Japan's decision was based on positive results from the DREAMM-7 and DREAMM-8 phase III trials evaluating Blenrep in combination with bortezomib plus dexamethasone (BVd) and in combination with pomalidomide plus dexamethasone (BPd), respectively, in patients with multiple myeloma who have received at least one prior therapy.
Earlier, an orphan drug designation for Blenrep was granted in Japan based on its ability to address high unmet need for patients with multiple myeloma.
GSK noted that 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 or PFS 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.
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D,GSK, 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."
Blenrep combinations are currently under review in all major markets globally, including in the US with a Prescription Drug User Fee Act (PDUFA) date of July 23, European Union, China, Canada, and Switzerland.
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