GSK's Blenrep Makes Comeback with UK Approval for Multiple Myeloma Combinations

GSK has secured a significant regulatory approval for its antibody-drug conjugate Blenrep, marking the therapy's return to the market after its global withdrawal in 2022. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has authorized Blenrep for use in two different combination treatments for multiple myeloma patients who have received at least one prior therapy.

Blenrep's New Lease on Life

The MHRA approval allows Blenrep to be used in combination with either Takeda's Velcade (bortezomib) or Bristol Myers Squibb's Pomalyst (pomalidomide), plus dexamethasone in second-line myeloma treatment. This world-first approval is a crucial step in GSK's ambitious plan for Blenrep to achieve peak annual sales exceeding 3 billion pounds sterling (approximately $4 billion).

Dr. Hesham Abdullah, GSK's global head of oncology R&D, emphasized the potential of Blenrep, stating, "As the only BCMA-targeted ADC therapy, Blenrep has the potential, supported by robust phase III data, to extend survival and remission versus standard of care and redefine treatment at or after first relapse."

Promising Clinical Trial Results

Blenrep's comeback is supported by impressive results from two combination trials. In the DREAMM-7 study, Blenrep in combination with Velcade and dexamethasone (Vd) demonstrated superior efficacy compared to Johnson & Johnson's Darzalex in a similar combination. The Blenrep-Vd regimen reduced the risk of disease progression or death by 59% and lowered the risk of death by 42% versus the Darzalex-based comparator.

The DREAMM-8 trial showcased Blenrep's efficacy when combined with Pomalyst and dexamethasone (Pd), resulting in a 48% reduction in the risk of progression or death compared to Velcade-Pd.

Global Regulatory Landscape and Market Competition

While the UK leads the way with this approval, Blenrep combinations are currently under review in 14 other territories. In the United States, the FDA is expected to deliver its verdict by July 23, 2025. As Blenrep re-enters the global market, it will face competition from powerful therapies like Johnson & Johnson and Legend Biotech's CAR-T therapy, Carvykti.

Dr. Joseph Mikhael from City of Hope and chief medical officer of the International Myeloma Foundation highlighted the importance of Blenrep's approval, stating, "As patients with multiple myeloma increasingly receive combination therapies at diagnosis, treatment options available in the community setting that use different mechanisms like Blenrep are crucial to extending remission and ultimately survival."

This regulatory milestone not only revitalizes Blenrep's market presence but also bolsters GSK's confidence in its long-term sales projections, with the company raising its 2031 sales target to over 40 billion pounds. As an off-the-shelf therapy, Blenrep offers a convenience advantage over CAR-T treatments, potentially reshaping the landscape of multiple myeloma treatment options available to patients and healthcare providers.