GSK's Blenrep Approval in the EU: A Strategic Catalyst for Long-Term Growth in Oncology

The European Medicines Agency's (EMA) recent endorsement of GSK's Blenrep (belantamab mafodotin) marks a pivotal turning point in the company's oncology strategy. Approved for the treatment of relapsed or refractory multiple myeloma (RRMM) in two combination regimens—bortezomib/dexamethasone (BVd) and pomalidomide/dexamethasone (BPd)—Blenrep's regulatory momentum in the EU, coupled with robust clinical data, positions GSK to capture significant market share in a high-growth therapeutic area. For investors, this is more than a regulatory win; it's a strategic catalyst for long-term value creation.

Regulatory Momentum: A Pathway to Market Leadership

The EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on May 22, 2025, paving the way for EU-wide approval by the European Commission in Q3 2025. This follows regulatory approvals in the UK (April 2025) and Japan (May 2025), with a U.S. FDA decision expected by July 23, 2025 under priority review. Blenrep's orphan drug designation in the EU and U.S. grants 10 years of market exclusivity, shielding it from direct competition and ensuring a stable revenue trajectory.

The regulatory journey for Blenrep has been anything but linear. After its initial accelerated approval in 2020 and subsequent withdrawal in 2024 due to the failure of the DREAMM-3 trial, GSK pivoted to combination therapies. The success of DREAMM-7 and DREAMM-8—pivotal phase III trials—has not only revived Blenrep's prospects but also redefined its role as a first-in-class BCMA-targeted therapy. This resilience underscores GSK's ability to adapt and innovate in the face of setbacks, a critical trait in the high-stakes world of oncology drug development.

Clinical Data: A Differentiated Efficacy Profile

The clinical evidence supporting Blenrep's approval is compelling. In DREAMM-7, the Blenrep-BVd combination nearly tripled median progression-free survival (PFS) compared to daratumumab-based regimens (36.6 months vs. 13.4 months; HR: 0.41). The trial also demonstrated a 42% reduction in mortality risk and a 3-year overall survival (OS) rate of 74% for Blenrep, versus 60% for the control group. In DREAMM-8, the Blenrep-pomalidomide-dexamethasone (BPd) regimen achieved a median PFS that was not yet reached at the time of analysis, compared to 12.7 months for the standard pomalidomide-dexamethasone arm. These results are not just statistically significant—they are clinically transformative.

What sets Blenrep apart is its manageable safety profile. While ocular toxicities (e.g., keratopathy) are a known concern, the rate of discontinuation due to these effects is ≤9%, far lower than the discontinuation rates seen with other therapies like daratumumab. Additionally, Blenrep's outpatient administration—requiring no complex pre-treatment protocols—makes it accessible in both academic and community settings, a critical advantage in markets facing oncology workforce shortages.

Market Dynamics: Capturing a $20 Billion Opportunity

The global multiple myeloma treatment market is projected to exceed $20 billion by 2027, with the EU representing a key growth corridor. Blenrep's approval in the EU positions GSK to compete directly with therapies like J&J's Carvykti and Bristol Myers Squibb's Abecma, both BCMA-targeted CAR-T therapies. However, Blenrep's logistical advantages—including its ability to be administered in-office—give it a distinct edge in community-based settings, where 70% of U.S. multiple myeloma patients receive treatment.

Moreover, Blenrep's combination therapy flexibility allows it to address multiple patient subgroups, including those refractory to lenalidomide or anti-CD38 therapies. This broad applicability, combined with its superior PFS and OS data, positions it to displace existing standards of care. Analysts project peak annual sales exceeding $1.5 billion, with potential to surpass $3 billion if the drug gains approval for earlier lines of therapy.

Investment Implications: A High-Conviction Play

For investors, Blenrep represents a high-conviction opportunity for several reasons:
1. Regulatory Tailwinds: With EU and U.S. approvals imminent, GSK is on track for commercial launches in key markets by late 2025.
2. Clinical Differentiation: Blenrep's PFS and OS data outperform existing therapies, supported by real-world evidence from Japan and the UK.
3. Market Exclusivity: Orphan drug designation ensures 10 years of protection, mitigating near-term competitive threats.
4. Strategic Fit: Blenrep aligns with GSK's broader shift toward high-margin specialty drugs, enhancing its oncology revenue mix.

Risks and Mitigants

While the outlook is bullish, investors should remain mindful of potential risks:
- Ocular Toxicity Management: GSK has developed a comprehensive plan for monitoring and mitigating ocular side effects, ensuring patient retention.
- Competition from CAR-T and Bispecifics: Blenrep's outpatient accessibility and manageable safety profile provide a clear differentiator.
- Pricing Pressures: GSK's partnerships with payers and risk-sharing agreements (e.g., with Blackstone for Sarclisa) demonstrate its ability to navigate pricing challenges.

Conclusion: A Strategic Win for GSK and Oncology Investors

GSK's Blenrep approval in the EU is more than a regulatory milestone—it's a testament to the company's commitment to innovation and resilience. With a $10 billion U.S. market and a $20 billion global opportunity, Blenrep is poised to become a cornerstone of GSK's oncology portfolio. For investors, this is a rare combination of robust clinical data, regulatory clarity, and commercial scalability—factors that rarely align in the biotech sector.

As the European Commission finalizes its approval in Q3 2025, and the FDA delivers its verdict in July, the stage is set for GSK to redefine standards of care in multiple myeloma. For those with a long-term horizon, this is a strategic investment opportunity not to be missed.