Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TYO: 4503) announced that the U.S. Food and Drug Administration (FDA) approved PADCEV (enfortumab vedotin) in combination with Keytruda (pembrolizumab) for perioperative treatment of adult patients with muscle‑invasive bladder cancer (MIBC) who are ineligible for cisplatin‑containing chemotherapy, based on the EV‑303/KEYNOTE‑905 Phase 3 trial showing a 60% reduction in recurrence, progression, or death risk.
Global Approvals: Already approved for locally advanced/metastatic urothelial cancer (la/mUC) in the U.S., Japan, and other markets; EU approved for la/mUC in platinum‑eligible patients; PADCEV monotherapy approved for la/mUC post‑PD‑1/platinum
Innovation: First perioperative ADC‑IO regimen in bladder cancer, addressing pre‑ and post‑surgical treatment
Clinical Evidence – EV‑303/KEYNOTE‑905 Trial
Endpoint
PADCEV + Keytruda vs. Surgery Alone
Primary (EFS)
60% risk reduction (HR = 0.40)
Event‑Free Probability
74.7% vs. 39.4% at 12 months
Median EFS
Not reached vs. 15.7 months
Overall Survival (OS)
50% risk reduction (key secondary)
Patient Population
Cisplatin‑ineligible MIBC patients (n=564)
Market Context & Outlook
Metric
Value
U.S. MIBC Incidence
~83,000 new cases (2024)
Cisplatin‑Ineligible Share
40‑45% (~35,000 patients)
Current Standard
Surgery alone; no approved perioperative regimens for this population
Peak Sales Forecast (PADCEV)
$2.5‑3.5 billion incremental by 2030 (U.S. MIBC indication)
Market Share Target
60‑70% of eligible patients
Competition
First‑in‑class; no direct ADC‑IO competitors in perioperative setting
Reimbursement Path: FDA approval enables immediate commercial access; CMS National Coverage Determination expected Q2 2026
Next Catalysts: EU filing for MIBC indication H1 2026; adjuvant expansion in post‑cystectomy patients Phase III underway
Forward‑Looking Statements This brief contains forward‑looking statements regarding PADCEV’s commercial performance, market penetration, and regulatory expansion. Actual results may differ materially due to risks including competitive responses, reimbursement negotiations, and real‑world clinical adoption.-Fineline Info & Tech
By Fineline Cube 