GSK's Blenrep Returns to the Myeloma Market in EU with Reapproval
Revitalized Key Asset with EU Reapproval
The European Union reapproved GSK's Blenrep (belantamab mafodotin) on July 23, 2025, for the treatment of relapsed or refractory multiple myeloma. Blenrep is an antibody-drug conjugate (ADC) that targets B-cell maturation antigen (BCMA) and delivers the cytotoxic agent MMAF. It is used in combination with bortezomib and dexamethasone or pomalidomide and dexamethasone. It can be used in patients who have received at least one prior treatment, shifting the BCMA-based competitive landscape from later-line to second-line therapy.
Efficacy Proven by DREAMM-7 and DREAMM-8
The approval is based on the randomized Phase 3 trials DREAMM-7 and DREAMM-8. In DREAMM-7, the median progression-free survival (PFS) for the Blenrep-bortezomib-dexamethasone group was 36.6 months, compared to 13.4 months for the Darzalex-bortezomib-dexamethasone group, with a 59% reduction in the risk of disease progression or death (HR 0.41, 95% CI 0.31–0.53, p<0.00001). In DREAMM-8, Blenrep-pomalidomide-dexamethasone reduced the risk by 48% compared to the control combination (HR 0.52, 95% CI 0.37–0.73, p<0.001), and the median PFS had not been reached at the time of analysis.
Shift from Monotherapy to Combination Therapy
Blenrep received conditional approval in the EU on August 25, 2020, but the European Commission did not renew the approval on February 23, 2024, after the confirmatory Phase 3 trial DREAMM-3 failed to meet its superiority endpoint. GSK shifted its development strategy from monotherapy to combination therapy with comparator agents in a three-drug regimen and secured a full marketing authorization. Japan approved the combination therapy on May 19, 2025, and the U.S. FDA approved Blenrep-bortezomib-dexamethasone for use after at least two prior therapies on October 23 of the same year.
Ocular Toxicity Influences Commercialization Speed
Separate from efficacy, corneal epithelial changes and visual impairment remain key limitations. In the U.S. DREAMM-7 approval cohort, ocular toxicity occurred in 92% of patients, with 77% experiencing Grade 3 or 4 events, and 83% required dose adjustments. The FDA applied a boxed warning and a Risk Evaluation and Mitigation Strategy (REMS). Additionally, the FDA Oncologic Drugs Advisory Committee in July 2025 voted 5 to 3 for BVd and 7 to 1 for BPd against the proposed dose's benefit-risk profile, meaning ophthalmic monitoring accessibility and dosing interval adjustments will determine real-world prescription penetration.
Entering a Darzalex-Dominated Market
The standard of care includes JNJ's Darzalex (daratumumab, CD38), BCMA CAR-T Carvykti (cilta-cel), and the BCMA-CD3 bispecific Tecvayli (teclistimab). Darzalex generated USD 14.351 billion in global sales in 2025, reflecting the commercial scale and dominance of the current standard of care in myeloma treatment. Blenrep, unlike CAR-T which requires customized manufacturing, is an ADC that can be supplied immediately. GSK has set a target of over GBP 3 billion in annual sales, but it must offset the burden of ocular toxicity management against efficacy to approach this goal.
The EU approval, based on the DREAMM-7 trial's 36.6-month PFS and HR 0.41, allows Blenrep to be used after at least one prior treatment, effectively restoring GSK's myeloma business. In the short term, it will directly compete with Darzalex, which recorded USD 14.351 billion in 2025 sales, in the second-line setting, while offering supply convenience over CAR-T Carvykti and bispecific Tecvayli. From an R&D perspective, it serves as a precedent for regulatory strategy in recovering asset value after monotherapy approval failure through Phase 3 combination trials. However, in the U.S., 92% ocular toxicity and 77% Grade 3/4 events with REMS implementation may limit adoption speed in the EU as well. Long-term enterprise value will be assessed by the gap between GSK's target of over GBP 3 billion in annual sales and the actual dose adjustment and discontinuation rates.
Source: EMA (ema)