In October 2025, the U.S. Food and Drug Administration (FDA) granted re-approval to belantamab mafodotin (Blenrep), GSK’s anti-BCMA antibody–drug conjugate (ADC), for use in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM).
The approval is based on results from the phase III DREAMM-7 trial, which demonstrated a significant improvement in progression-free survival (PFS). Blenrep, once withdrawn from the market, now returns with stronger data supporting its clinical benefit.
DREAMM-7 Trial Summary
- Population: Patients with relapsed/refractory multiple myeloma
- Arms: Blenrep + bortezomib + dexamethasone vs daratumumab-based combination
- Primary endpoint: Progression-free survival (PFS)
- Result: Blenrep reduced risk of disease progression by approximately 50% (HR=0.50)
- Overall response rate (ORR): ~80% for Blenrep vs ~60% for comparator
Ocular toxicity and keratopathy were manageable, with improved tolerability through optimized dosing intervals and ophthalmic monitoring.
Clinical Significance
This re-approval marks a pivotal moment for BCMA-targeted therapy. Unlike CAR-T or bispecific antibodies, Blenrep offers an off-the-shelf ADC option that can be readily administered in standard oncology settings, broadening access to BCMA-directed treatments.
It also reflects the FDA’s evolving stance toward post-market data and real-world safety optimization — emphasizing adaptability rather than permanent withdrawal.
Future Outlook
GSK continues to explore combination strategies integrating Blenrep with immune checkpoint inhibitors and novel BCMA modulators. Efforts are focused on extending durability of response and mitigating toxicity, particularly ocular side effects.
This re-approval signals the beginning of “Chapter Two” in BCMA therapeutics — where optimized linker–payload chemistry, refined dosing, and safety management will define the next-generation ADC paradigm.
Author’s Perspective
Blenrep’s comeback is more than a reinstatement — it represents a redefinition of practical oncology. By aligning trial rigor with clinical usability, it demonstrates that safety optimization and patient-centered design are now integral to regulatory success. As the ADC field matures, Blenrep’s trajectory highlights the industry’s shift toward therapies that are safer, longer-lasting, and operationally simpler.
This article was produced by the Morningglorysciences Editorial Team.
Oncology FDA Approval
・2025
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