Blenrep’s Breakthrough: Why GSK’s Oncology Win Positions It for a Turnaround

The recent approval of GlaxoSmithKline’s (GSK) Blenrep combinations in Japan marks a pivotal moment for the company’s oncology portfolio. With multiple myeloma—a blood cancer with grim survival odds—still lacking effective treatments, Blenrep’s Phase III data and regulatory momentum position GSK to capitalize on a $40 billion market. Now trading at a 21% year-to-date (YTD) discount, the stock offers a compelling entry point ahead of a critical U.S. FDA decision in July 2025. Here’s why investors should act now.

Japan Approval: Validation of Clinical Superiority

On May 19, 2025, Japan’s Ministry of Health granted approval for Blenrep in combination with bortezomib/dexamethasone or pomalidomide/dexamethasone for relapsed/refractory multiple myeloma. This decision was grounded in DREAMM-7 and DREAMM-8 trial data, which demonstrated Blenrep’s dominance over standard therapies.

In DREAMM-7, Blenrep/BVd cut the risk of death by 42% compared to daratumumab-based therapy, with a three-year overall survival (OS) rate of 74% versus 60%. DREAMM-8 further showed a 71% one-year progression-free rate for Blenrep/BPd, outperforming bortezomib-based regimens. These results, published in the New England Journal of Medicine, underscore Blenrep’s ability to tackle a disease where only 43% of patients survive five years post-diagnosis.

Orphan Exclusivity and Global Rollout: A Shield Against Competition

Blenrep’s orphan drug designation in Japan—a recognition of its role in addressing a high unmet need—grants market exclusivity, protecting GSK’s position until 2029. While the EU withdrew Blenrep’s monotherapy approval in 2024 due to safety concerns, combination data has revived its prospects. The U.S. FDA’s July 23 PDUFA date looms large, with applications also under review in the EU, China, and Canada.

Why the Stock Is Undervalued—And Set to Rebound

GSK’s shares have fallen 21% YTD, partly due to broader sector volatility and lingering concerns over Blenrep’s past monotherapy risks. However, this decline has created a rare opportunity:

1. Valuation Discount: GSK’s forward P/E ratio of 8.73 (as of February 2025) is a 40% discount to the global healthcare sector average, despite its pipeline momentum.
2. Catalysts Ahead: The FDA’s July decision and China’s priority review (with Breakthrough Therapy Designation) could unlock $1.2 billion in annual sales by 2030.
3. Pipeline Repositioning: Blenrep’s success renews focus on GSK’s oncology franchise, which includes next-gen BCMA-targeted therapies and immuno-oncology assets.

Analysts now project a 12-month price target of £40.13, implying a 20% upside from current levels. While risks like U.S. pricing negotiations exist, Blenrep’s administerability (no complex pre-treatment steps) and community oncology suitability favor broad adoption.

The Bull Case: A Turnaround in the Making

GSK’s stock has underperformed peers despite its oncology growth drivers. The Japan approval, paired with the FDA’s looming decision, could catalyze a rerating. Key catalysts include:
- Positive U.S. FDA action, which would validate Blenrep’s global potential.
- DREAMM trial data driving uptake in first-line myeloma, where Blenrep’s mechanism (anti-BCMA ADC) offers a novel alternative to bispecific antibodies.
- Share buybacks and a 4.7% dividend yield (2025 estimates), providing a safety net for investors.

Conclusion: Act Before the FDA Speaks

Blenrep’s clinical and regulatory milestones position GSK as a leader in multiple myeloma—a field where innovation has stalled. With a low valuation, a high probability of FDA approval, and a $2 billion oncology pipeline, the stock is primed for a rebound. Investors ignoring this catalyst risk missing a multi-quarter rally. The question isn’t whether to buy, but whether to wait.

Action Now: Buy GSK shares ahead of the July FDA decision. The risk-reward here favors aggressive investors poised to capitalize on an undervalued oncology powerhouse.