GSK’s Combo Comeback: How Blenrep’s Japanese Nod Could Redefine Oncology Portfolios

GSK plc. by combining its anti-BCMA antibody-drug conjugate (ADC), Blenrep (belantamab mafodotin), with conventional treatments, is improving the treatment of blood cancer in Japan. The U.S., EU, Canada, China, and Switzerland have already begun FDA.

In May 2025, the Japanese Ministry of Health, Labour & Welfare (MHLW) authorised the use of pomalidomide and dexamethasone (BPd) or bortezomib and dexamethasone (BVd) in conjunction with Blenrep for adult patients aging above 18 with refractory or recurrent multiple myeloma.

Hesham Abdullah, SVP & Global Head Oncology R&D, GSK, said "that today’s approval brings the benefits of Blenrep combinations to patients with relapsed or refractory multiple myeloma in Japan."

Why It Matters

• Phase III trials DREAMM 7 (BVd vs. DVd) and DREAMM 8 (BPd vs. PVd) showed a 42% decrease in mortality risk and significant gains in progression-free survival. Both studies showed deeper and longer-lasting responses compared to standard regimens, including in patients who had previously been treated with lenalidomide or daratumumab. According to these results, individuals with relapsed or refractory multiple myeloma may find that blenrep-based combinations become the new standard of care.

María-Victoria Mateos, MD, PhD, Head of Myeloma and Clinical Trials Unit, Haematology Department and Professor of Medicine at the University of Salamanca, Spain, and DREAMM-7 principal investigator, said “When considering patients with multiple myeloma who have relapsed or grown resistant to initial treatment, the entirety of the results from DREAMM-7 may represent a paradigm change. In comparison to the daratumumab combination used as standard treatment, the OS outcomes obtained with the belantamab mafodotin combination in DREAMM-7 further support the regimen's ability to extend the lives of patients with relapsed or refractory multiple myeloma.”

• Blood cancer is a potentially fatal illness in Japan, and only more than 43 percent of individuals survive five years after receiving a diagnosis. It is the third most prevalent blood tumour worldwide, despite being curable. Over 7,200 new cases are diagnosed in Japan annually.

Key Impacts of this Approval:

• Brings cutting‑edge BCMA‑ADC combos to Japanese myeloma patients.
• Validates and accelerates anti‑BCMA combo strategies in global oncology pipelines.
• Reinforces GSK’s clinical development leadership through dream trials.
• Propels ongoing regulatory reviews worldwide (U.S. PDUFA July 23, 2025. EU, Canada, China, Switzerland)
• Supports future insurance reimbursements and expanded access models.

The Bigger Picture

• Blenrep is the only anti-BCMA ADC currently licensed for myeloma. It minimises harm to healthy tissues by delivering a strong cytotoxic chemical straight to cancer cells that express BCMA. Blenrep is an important treatment option for patients with blood tumour because of its targeted mechanism and clinical success.
• This is the second significant regulatory approval for the treatment of multiple myeloma that has relapsed or is refractory. Following the first Blenrep combination to be approved globally by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) last month.
• Positive EMA review, priority reviews in China, and U.S. filings signal a wave of global approvals in 2025.