On July 10th, 2026, the U.S. Food and Drug Administration (FDA) approved pembrolizumab,Keytruda in combination with enfortumab vedotin (Padcev,) for use both before and after bladder removal surgery (radical cystectomy) in adults with muscle-invasive bladder cancer (MIBC).
The approval is significant for two reasons: it introduces a treatment strategy that spans both the neoadjuvant (before surgery) and adjuvant (after surgery) settings, and it expands access to all patients who are candidates for bladder removal surgery, rather than only those who were unable to receive cisplatin chemotherapy.
What changed?
Previously, this combination had only been approved for a narrower group of patients with MIBC. Now, with the expanded approval, patients who are eligible for cisplatin chemotherapy can also access this regimen, giving doctors another evidence-based treatment option to consider before surgery.
What did the clinical trial show?
The FDA based its decision on results from the phase III KEYNOTE-B15/EV-304 trial, which enrolled 808 adults with previously untreated MIBC who were eligible for bladder removal surgery.
Researchers compared two approaches:
- Pembrolizumab plus enfortumab vedotin before surgery, followed by the same combination after surgery
- Standard neoadjuvant (before surgery) chemotherapy (gemcitabine plus cisplatin) followed by surgery
The results favored the pembrolizumab and enfortumab vedotin combination.
Compared with standard chemotherapy, patients receiving the new regimen experienced a 47% reduction in the risk of recurrence, disease progression, or death (known as event-free survival) and a 35% reduction in the risk of death, demonstrating an overall survival benefit
The safety profile of the combination was consistent with what has been observed in previous studies of these medications in bladder cancer.
Why is this important?
MIBC has a high risk of coming back, even after the bladder is surgically removed, which is why researchers have been looking for additional ways to treat the disease beyond surgery alone.
This approval is important because it supports a treatment strategy that addresses cancer at multiple points:
- Before surgery, to shrink the tumor and begin treating cancer cells throughout the body.
- After surgery, to help destroy any remaining microscopic cancer cells that can’t be detected on scans but could cause the cancer to return.
What this means for patients
For people newly diagnosed with MIBC who are planning to undergo bladder removal surgery, this approval offers another treatment option to discuss with their care team.
Rather than relying on chemotherapy before surgery alone, some patients may now be candidates for a treatment plan that combines immunotherapy and targeted therapy before surgery and continues treatment afterward.
Whether this regimen is appropriate depends on many factors, including your overall health, treatment goals, and your oncologist’s recommendation. This expanded FDA approval gives patients and providers another evidence-based option that has been shown to improve outcomes in a large clinical trial.
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