Pfizer Surges After FDA Approves Key Bladder Cancer Drug Combo
The approval for PADCEV with Merck’s Keytruda validates Pfizer's $43 billion Seagen acquisition and establishes a new standard of care in a growing oncology market.
Shares of Pfizer (NYSE: PFE) jumped more than 3% in morning trading after the U.S. Food and Drug Administration (FDA) approved a combination therapy of its drug PADCEV with Merck’s (NYSE: MRK) KEYTRUDA for the treatment of certain forms of advanced bladder cancer. The decision marks a significant victory for Pfizer’s oncology division and provides a crucial validation of its $43 billion acquisition of Seagen, the drug's original developer.
Pfizer’s stock rose 3.67% to $25.29, while collaborator Merck saw its shares climb 4.85% to $99.57 on the news. The approval covers the use of PADCEV (enfortumab vedotin-ejfv) in combination with the blockbuster immunotherapy KEYTRUDA (pembrolizumab) for patients with locally advanced or metastatic urothelial carcinoma. This regulatory milestone positions the combination therapy as a new first-line standard of care, addressing a critical need for more effective treatments in a challenging disease area.
The FDA's decision was based on compelling data from the KEYNOTE-905/EV-303 clinical trial. The study demonstrated that the combination therapy led to a 60% reduction in the risk of disease recurrence, progression, or death compared to previous treatments. According to the FDA's announcement, the results were substantial enough to establish a new benchmark for efficacy in this patient population.
This approval is a cornerstone of Pfizer's strategy to become a dominant force in oncology, a plan significantly accelerated by its acquisition of Seagen, which closed in late 2023. PADCEV, an antibody-drug conjugate, was a centerpiece of the deal, and its success is pivotal to delivering returns on the substantial investment. Pfizer has previously stated it expects its genitourinary cancer portfolio, anchored by PADCEV, to become its largest oncology franchise by 2030.
The bladder cancer therapeutics market is a significant and growing commercial opportunity. Valued at an estimated $5.68 billion in 2025, the market is projected to expand to over $9.5 billion by 2034, driven by an aging population and the introduction of innovative immunotherapies and targeted treatments. By securing a position as a first-line therapy, the PADCEV-KEYTRUDA combination is poised to capture a substantial share of this market.
Despite the positive catalyst, the broader analyst community maintains a cautiously optimistic outlook on Pfizer. The consensus rating for the stock remains a 'Hold', with an average price target of around $29.00. While some analysts, like Scotiabank, recently initiated coverage with a 'sector outperform' rating and a $30 target, others, including Goldman Sachs, have reiterated a 'neutral' stance. The sentiment reflects the company's ongoing challenges, including navigating the post-COVID revenue decline and advancing a large and complex pipeline.
For Merck, the approval further cements the dominance of KEYTRUDA, its flagship immunotherapy drug, which is approved across a wide range of cancer types. Combination therapies are a key part of Merck's strategy to extend the drug's lifecycle and clinical utility, and the synergy with PADCEV opens a new and lucrative treatment avenue.
Looking forward, investors will be closely watching the commercial rollout and initial sales figures for the combination therapy. The successful market adoption of the PADCEV-KEYTRUDA regimen will be a critical indicator of Pfizer's ability to integrate the Seagen assets effectively and re-energize its growth narrative beyond its COVID-19 vaccine franchise.