GSK's Blenrep Approval: A Strategic Landmark for Oncology Dominance in Europe

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a pivotal positive opinion for GlaxoSmithKline's (GSK) Blenrep (belantamab mafodotin) for the treatment of relapsed or refractory multiple myeloma. This decision, finalized on May 23, 2025, marks a transformative moment for GSK's oncology portfolio and solidifies its position as a leader in advanced cancer therapies. The approval, which covers two combination regimens (Blenrep with bortezomib/dexamethasone and pomalidomide/dexamethasone), is the culmination of years of clinical development and represents a breakthrough in addressing a critical unmet need in one of the deadliest blood cancers.

Strategic Implications for GSK's Oncology Portfolio

GSK's oncology division has long been overshadowed by its success in vaccines and HIV therapies, but Blenrep's approval signals a bold repositioning. Multiple myeloma, a cancer of plasma cells with a five-year survival rate of just 55% in the UK, lacks curative options, and relapse is inevitable for most patients. Blenrep, an antibody-drug conjugate (ADC) targeting the B-cell maturation antigen (BCMA), offers a novel mechanism of action that outperforms existing standards. The Phase III DREAMM-7 trial demonstrated a 36.6-month median progression-free survival (PFS) for Blenrep plus bortezomib/dexamethasone versus 13.4 months for daratumumab-based therapy, with a 42% reduction in mortality risk. In DREAMM-8, the BPd combination achieved a 52% risk reduction in progression, underscoring Blenrep's efficacy across treatment lines.

This data positions Blenrep as a first-line therapy candidate, a strategic shift from its previous use as a late-line option. By inserting itself into earlier treatment regimens, GSK gains a competitive edge over rivals like Amgen's Carvykti (a BCMA-targeted CAR-T therapy) and Bristol-Myers Squibb's Blenrep competitor, elotuzumab. Unlike CAR-T therapies, Blenrep's ADC design allows outpatient administration without the logistical and cost burdens of cell-based treatments, making it accessible to broader patient populations.

Securing EU Market Dominance

The EU's regulatory nod is particularly impactful given the region's €50 billion oncology market, projected to grow at 6% annually through 2030. Multiple myeloma alone affects over 30,000 new patients annually in Europe, and Blenrep's orphan drug designation grants GSK 10 years of market exclusivity—a critical advantage in a space crowded with emerging therapies. The drug's combination approach also leverages existing drugs (e.g., bortezomib, pomalidomide), ensuring seamless integration into current clinical pathways and accelerating adoption by oncologists.

Global Momentum Fuels Investment Case

While the EU approval is a cornerstone, Blenrep's global progress amplifies its value. The U.S. FDA has set a PDUFA date of July 2025, with Japan and Canada also nearing decisions. If approved, Blenrep could capture $1.5–2 billion in annual sales by 2030, driven by its first-in-class status and strong trial data. Additionally, GSK's strategic partnerships, such as its collaboration with Dova Pharmaceuticals to optimize Blenrep's dosing and mitigate ocular side effects, reduce execution risks and enhance long-term commercial viability.

Risks and Considerations

Skeptics may question competition from CAR-T therapies or BCMA-targeted bispecific antibodies. However, Blenrep's superior PFS and OS data in head-to-head trials, coupled with its ease of use, position it as a best-in-class option. While pricing negotiations in EU member states could pressure margins, GSK's track record in value-based pricing—such as its HIV drug pricing agreements—suggests it can navigate this challenge effectively.

Conclusion: A Compelling Growth Catalyst

GSK's Blenrep approval is more than a regulatory win—it's a strategic masterstroke that cements the company's oncology leadership. With a robust pipeline, global market access, and a therapy that delivers meaningful survival benefits, GSK is primed to capitalize on a multibillion-dollar opportunity. Investors should view this as a buy signal, as Blenrep's EU approval sets the stage for sustained growth in oncology, a sector where innovation and execution define winners. The time to act is now, as the countdown to broader approvals—and commercialization—has already begun.