GSE Announces China NMPA Approval of Blenrep for Treatment of Adult Patients with Relapsed or Refractory Multiple Myeloma

In April 2026, the National Medical Products Administration of China granted approval for GSK’s Blenrep (belantamab mafodotin) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. This decision follows positive results from the pivotal DREAMM-2 Phase II trial, which demonstrated a clinically meaningful overall response rate in a heavily pretreated population with high-risk cytogenetic features. The approval marks a significant advancement in targeted therapy for a disease that remains incurable despite recent therapeutic innovations, offering a new mechanism of action for patients exhausting conventional options.

Key Clinical Takeaways:

• Blenrep is an antibody-drug conjugate targeting B-cell maturation antigen (BCMA), delivering a cytotoxic payload directly to plasma cells in multiple myeloma.
• The DREAMM-2 trial showed an overall response rate of 31% and a median duration of response of 11 months in patients with triple-class refractory disease.
• Ocular toxicity, particularly keratopathy, remains a significant adverse effect requiring proactive monitoring and dose modification strategies.

Multiple myeloma, a plasma cell malignancy characterized by bone destruction, renal impairment, and immunosuppression, affects over 176,000 individuals globally each year, with nearly 117,000 deaths annually according to the latest GLOBOCAN estimates. Despite the advent of proteasome inhibitors, immunomodulatory drugs, and monoclonal antibodies, most patients eventually relapse due to clonal evolution and microenvironment-mediated resistance. BCMA, a tumor necrosis factor receptor superfamily member highly expressed on malignant plasma cells, has emerged as a promising target for immunotherapy. Blenrep utilizes a humanized anti-BCMA monoclonal antibody linked to monomethyl auristatin F (MMAF) via a protease-cleavable linker, enabling targeted delivery of the cytotoxic agent upon antigen binding and internalization. This mechanism minimizes systemic exposure while maximizing tumor cell kill, representing a paradigm shift from conventional chemotherapy.

The approval in China is grounded in the DREAMM-2 study, a single-arm, open-label Phase II trial published in The Lancet Oncology in 2020, which enrolled 97 patients with relapsed/refractory multiple myeloma who had received a median of five prior lines of therapy. Funded by GlaxoSmithKline, the study reported an overall response rate of 31% (95% CI: 22–42), including two complete responses and 28 partial responses, with a median progression-free survival of 2.8 months and median duration of response of 11.1 months. Notably, responses were observed irrespective of prior exposure to BCMA-targeted therapies or high-risk cytogenetics such as del(17p) or t(4. 14). The most common grade 3 or higher adverse events were thrombocytopenia (20%), anemia (16%), and keratopathy (15%), the latter necessitating routine ophthalmologic evaluations and dose holding per modified RECIST criteria for corneal events.

“Blenrep addresses a critical unmet need in the quadruple-refractory myeloma space, where therapeutic options are exceedingly limited. Its mechanism offers precision targeting, but the ocular safety profile demands integrated care between oncologists and ophthalmologists to optimize benefit-risk balance.”

While Blenrep’s approval represents a valuable addition to the armamentarium, its positioning in the treatment sequence remains under investigation. Ongoing Phase III trials such as DREAMM-3 and DREAMM-7 are evaluating belantamab mafodotin in combination with standard backbones like pomalidomide-dexamethasone or daratumumab-pomalidomide-dexamethasone to determine whether synergistic effects can improve progression-free survival without exacerbating toxicity. Early signals from DREAMM-3 suggest improved response rates when combined with immunomodulatory agents, though final overall survival data are pending. Regulatory agencies including the FDA and EMA have previously issued complete response letters due to concerns over survival benefit and retinal toxicity, underscoring the importance of real-world evidence post-approval.

“The future of BCMA-directed therapy lies not in monotherapy but in rational combinations and sequential targeting. Blenrep’s role will be defined by how well we integrate it into evolving regimens that anticipate resistance mechanisms from the outset.”

For patients navigating complex relapsed myeloma trajectories, access to specialized care is paramount. Individuals experiencing disease progression after triplet-based regimens should seek evaluation at centers with expertise in novel immunotherapies and clinical trial availability. It is strongly advised to consult with vetted board-certified oncologists who possess deep experience in plasma cell disorders and can assess eligibility for advanced therapies like Blenrep or enrollment in investigational studies. Managing treatment-associated ocular toxicity requires proactive surveillance; patients should establish care with specialized ophthalmologists familiar with drug-induced keratopathy protocols to enable early intervention and dose optimization. Healthcare systems aiming to integrate such targeted therapies must also consider logistical and safety infrastructure, making collaboration with certified clinical trial coordinators essential for protocol adherence, adverse event tracking, and patient education in real-world settings.

As the myeloma treatment landscape evolves toward triplet and quadruplet regimens incorporating immunotherapies, antibody-drug conjugates like Blenrep exemplify the promise of precision oncology — yet their value is maximized only within multidisciplinary frameworks that prioritize safety, sequencing, and patient-centered monitoring. Continued investment in biomarker-driven strategies and combination approaches will be critical to transforming transient responses into sustained remissions.

*Disclaimer: The information provided in this article is for educational and scientific communication purposes only and does not constitute medical advice. Always consult with a qualified healthcare provider regarding any medical condition, diagnosis, or treatment plan.*