PADCEV® Gains Pivotal FDA Nod in Bladder Cancer

New York, U.S. – November 21, 2025 – PADCEV® (enfortumab vedotin-ejfv) has received full approval from the U.S. Food and Drug Administration (FDA) for use in combination with KEYTRUDA® (pembrolizumab) as a perioperative regimen – administered before and after surgery – in adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. pfizer.com+2U.S. Food and Drug Administration+2

Landmark Approval for PADCEV

This approval marks a critical milestone for PADCEV, delivering the first and only sanctioned perioperative combination of an antibody-drug conjugate (ADC) and a PD-1 inhibitor in the MIBC space. The decision is grounded in robust data from the pivotal Phase 3 EV-303 (KEYNOTE-905) trial, which demonstrated:

• A 60% reduction in risk of disease recurrence, progression or death for the PADCEV + KEYTRUDA arm versus surgery alone (HR = 0.40; 95% CI 0.28-0.57; p < 0.0001) with event-free survival (EFS) as the primary endpoint. pfizer.com+1
• A 50% reduction in the risk of death (overall survival, OS) compared to surgery alone (HR = 0.50; 95% CI 0.33-0.74; p = 0.0002). pfizer.com+1
• In the trial, 74.7% of patients receiving the PADCEV + KEYTRUDA regimen remained event-free at two years, compared to 39.4% of those treated with surgery alone. www.pharmabiz.com

The approval applies to adult patients with MIBC who are ineligible for cisplatin-based chemotherapy — a group that previously had limited therapeutic options and high risk of relapse even after surgery.

Therapeutic Context & Strategic Relevance

PADCEV’s approval in this setting significantly elevates the therapeutic landscape for bladder cancer. For years, patients with MIBC who could not receive cisplatin — due to comorbidity or other factors — faced poor prognosis and limited interventions. By offering a credible perioperative regimen, PADCEV in combination with KEYTRUDA stands to become a new standard of care.

The significance for oncology stakeholders is clear:

• Expanded application of PADCEV moves the drug beyond previously approved indications (such as locally advanced or metastatic urothelial carcinoma) into earlier-stage, high-unmet-need treatment settings.
• Strategic value creation: For the sponsor organisations, this new indication potentially enlarges PADCEV’s addressable market, strengthens its clinical value proposition and supports long-term growth dynamics.
• Operational shift: Hospitals, oncology centres and treatment networks must now adjust protocols to incorporate this perioperative combination therapy, including coordination between surgical, medical oncology and perioperative care teams.

Integration Into Clinical Practice

With the approval now secured, rollout of PADCEV in combo with KEYTRUDA will involve several key steps and considerations:

• Education of surgical and oncology teams about the new regimen, including patient eligibility criteria, perioperative timing (neoadjuvant + adjuvant), monitoring and safety profile.
• Integration of PADCEV + KEYTRUDA into treatment pathways for cisplatin-ineligible MIBC patients — particularly in multidisciplinary tumour boards and uro-oncology clinics.
• Engagement with payors and health-system stakeholders to secure reimbursement and access pathways for the new indication, given its high-impact clinical data and potential to shift care standards.
• Monitoring of real-world data as adoption accelerates, including safety, event-free outcomes, and overall survival in routine clinical settings beyond the trial environment.

Safety Profile & Patient Considerations

As with all oncology therapies, PADCEV combination regimens carry potential risks and require careful patient selection and management. The safety findings from EV-303 remain consistent with prior PADCEV and KEYTRUDA monotherapy data: key adverse events include rash, fatigue, peripheral neuropathy, elevated liver enzymes and other treatment-related events. Physicians should assess individual patient comorbidities (especially those that preclude cisplatin) and manage infusion/treatment timelines accordingly.

Market Opportunity & Commercial Outlook

From a commercial perspective, this approval is a major growth driver for PADCEV. Key factors influencing business and market outlook include:

• Earlier-stage indication (perioperative) often implies larger patient populations than later-line metastatic settings.
• Surgery-adjunct therapies typically integrate within broader care pathways, increasing treatment volume and uptake potential.
• Combination therapy (PADCEV + KEYTRUDA) may command premium positioning and improved payor reimbursement due to its superior outcome data.
• For the sponsor companies, launching an oncology drug into a new setting with first-in-class status strengthens competitive positioning and enhances brand portfolio.

Implications for Corporate Communications

For companies using platforms like Ixoraly to distribute this news, several communication principles apply:

• Highlight “PADCEV” consistently as the focus keyword to optimise search-engine visibility and ensure clarity of message.
• Lead with the approval headline, reference key trial data early (60% risk reduction, 50% survival benefit) and emphasize the “first/only” phrasing (first and only perioperative ADC + PD-1 inhibitor combination).
• Provide context around patient-need (cisplatin-ineligible MIBC), trial design (EV-303), and strategic relevance to the organisation’s oncology business.
• Include sectioned content: approval details, trial highlights, market context, clinical implementation, safety and next steps. This helps readability for media, investors and healthcare stakeholders.
• Embed quotes from leadership (CEOs, Chief Oncology Officer, investigators) to lend voice and credibility to the announcement.
• Ensure a forward-looking statement section addresses anticipated launch timing, reimbursement planning, and global rollout initiatives.

About Ixoraly

Ixoraly is a global press release and corporate-news distribution platform specialising in business-critical announcements within healthcare, technology, life sciences and beyond. Ixoraly enables companies to publish and amplify strategic disclosures—such as regulatory approvals, partnership transactions, product launches and clinical-trial milestones—to media, investors, analysts and digital audiences worldwide. With an emphasis on SEO-optimised content, clarity and professional reach, Ixoraly supports organisations in shaping their public narrative and achieving maximum impact.