GSK's Blenrep Makes Comeback with FDA Approval for Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has approved the return of GSK's multiple myeloma drug Blenrep, marking a significant turnaround for the once-withdrawn medication. The approval comes with a more limited label than initially anticipated, positioning Blenrep as a combination treatment for patients who have received at least two prior lines of therapy.

Approval Details and Clinical Data

Blenrep (belantamab mafodotin) has been approved in combination with Takeda's Velcade (bortezomib) and the corticosteroid dexamethasone (BVd) for adults with relapsed or refractory multiple myeloma. This approval is based on results from the Phase III DREAMM-7 trial, which showed impressive efficacy improvements over existing treatments.

In the DREAMM-7 study, the Blenrep combination reduced the risk of death by 51% and tripled the median progression-free survival to 31.3 months, compared to 10.4 months for a daratumumab-based triplet regimen. Tony Wood, GSK's Chief Scientific Officer, emphasized the urgent need for novel therapies in multiple myeloma, where nearly all patients experience relapse.

Regulatory Journey and Market Implications

Blenrep's path to reapproval has been complex. Initially approved in 2020 as a monotherapy for fourth-line treatment, it was voluntarily withdrawn from the market in 2022 after failing a confirmatory trial. The recent FDA decision came despite a negative vote from the Oncologic Drugs Advisory Committee in July 2025, which raised concerns about dosing, safety issues, and trial demographics.

The FDA's approval is more conservative than GSK's original application, which sought second-line use. The current label specifies Blenrep's use in patients who have undergone at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

Competitive Landscape and Market Positioning

As Blenrep re-enters the U.S. market, it faces a evolved treatment landscape. CAR-T therapies like Johnson & Johnson and Legend Biotech's Carvykti have gained momentum, while J&J's Darzalex remains a dominant force in multiple myeloma treatment.

GSK is positioning Blenrep as the only anti-BCMA agent that can be administered across various healthcare settings, including community centers where 70% of patients receive care. This accessibility could provide a competitive edge, particularly for older or more frail patients.

Despite the more limited approval, GSK maintains that Blenrep will be a "material growth driver" in the coming years. The company previously estimated peak sales potential at over £3 billion (approximately $4 billion), although this was based on a broader approval in second-line treatment.