Merck Gains FDA Nod for Keytruda Combo in Bladder Cancer
Approval for use with Pfizer/Astellas's Padcev establishes a new standard of care for first-line treatment, bolstering the blockbuster drug's market dominance.
Merck (MRK) has secured a pivotal U.S. Food and Drug Administration (FDA) approval for its blockbuster immunotherapy drug, Keytruda, in combination with Pfizer (PFE) and Astellas Pharma's Padcev for the treatment of advanced bladder cancer. The decision, which covers patients with locally advanced or metastatic urothelial carcinoma, significantly expands Keytruda's market and reinforces its position as a cornerstone of modern cancer therapy.
Shares of Merck rose nearly 5% in morning trading following the announcement, reflecting investor confidence in the expanded label for the company's most important product. The approval solidifies the combination therapy as a new first-line standard of care, a critical designation in the competitive oncology market.
Keytruda is the undisputed engine of Merck’s financial performance, generating immense revenue that fuels the company's research and development pipeline. The drug accounted for approximately 45% of Merck's total revenue in the third quarter of 2024, with sales reaching $7.4 billion. This latest approval is crucial for sustaining that growth trajectory as the company works to expand Keytruda's applications ahead of its eventual patent expiration.
The FDA's decision is backed by compelling clinical data showing the combination therapy provides dramatic improvements in overall and progression-free survival for patients. According to clinical trial results, the pairing of Keytruda's immune-boosting mechanism with Padcev, an antibody-drug conjugate that delivers a targeted toxin to cancer cells, has proven to be a highly effective strategy against advanced bladder cancer.
This approval also highlights a significant trend in oncology: the strategic pairing of different drug classes to create more potent treatments. By combining its PD-1 inhibitor with Pfizer and Astellas's therapy, Merck not only enhances its own drug's utility but also creates a higher barrier to entry for competitors. The collaboration brings together two of the world's largest pharmaceutical giants to address a significant unmet medical need.
For its part, Pfizer, which partners with Japan-based Astellas on Padcev, also stands to benefit from the expanded use of its drug. Shares of Pfizer saw a modest rise of over 3.6% on the news.
The competitive landscape for bladder cancer includes other immunotherapies such as Roche's Tecentriq and Bristol Myers Squibb's Opdivo. However, by securing the first-line combination therapy approval, Merck and its partners have established a formidable position that competitors will find challenging to overcome. Analysts will be watching closely to see how quickly the Keytruda-Padcev regimen is adopted by oncologists.
Looking ahead, Merck continues to innovate around its flagship product. The company is developing a subcutaneous formulation of Keytruda, which could launch by 2025. This under-the-skin injection would offer greater convenience than the current intravenous infusion, helping to protect the franchise's market share from biosimilar competition in the future. Today's FDA decision further cements the drug's legacy and its central role in Merck's strategy for the years to come.