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News|Articles|November 13, 2026

FDA Approves Imfinzi Plus Padcev for Some With Muscle-Invasive Bladder Cancer

Author(s)CURE staff
Fact checked by: Spencer Feldman
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Key Takeaways

  • Perioperative durvalumab plus enfortumab vedotin is now an FDA-approved option for MIBC when cisplatin-based chemotherapy is not feasible or is declined, integrating systemic therapy around cystectomy.
  • VOLGA met its primary endpoint, reducing event risk by 49% versus surgery alone; median EFS was not reached with combination therapy versus 12.1 months with surgery alone.
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The FDA approved Imfinzi plus Padcev before and after surgery for adults with muscle-invasive bladder cancer who cannot or will not receive cisplatin.

The Food and Drug Administration (FDA) has approved Imfinzi (durvalumab) in combination with Padcev (enfortumab vedotin-ejfv) for adults with muscle-invasive bladder cancer (MIBC) who are not eligible for, or who decline, cisplatin-based chemotherapy.

Under the approval, announced Nov. 13, 2026, patients receive Imfinzi and Padcev together before radical cystectomy, a surgery to remove the bladder. After surgery, they continue on Imfinzi alone.

Why did the FDA approve Imfinzi plus Padcev in muscle-invasive bladder cancer?

The FDA based its approval on results from the VOLGA trial. In that trial, people who received Imfinzi and Padcev before and after surgery had a lower risk of their cancer returning, worsening or causing death than people who had surgery alone. They also lived longer.

The FDA granted the application priority review and approved it six weeks ahead of its goal date. The application was also reviewed under Project Orbis, an FDA program that lets regulators in several countries review cancer treatments at the same time. The other reviewers were Australia, Brazil, Canada, Israel, Singapore and the United Kingdom.

What did the VOLGA trial show for Imfinzi plus Padcev?

The trial’s main goal was to measure event-free survival. This is the length of time patients lived without their cancer progressing in a way that ruled out surgery, coming back after surgery, or causing death.

Patients who received Imfinzi and Padcev had a 49% lower risk of these events than patients who had surgery alone. Median event-free survival, the point at which half of patients had experienced an event, had not yet been reached in the Imfinzi and Padcev group. In the surgery-alone group, it was 12.1 months.

The combination also lowered the risk of death by 42% compared with surgery alone. Median overall survival had not been reached in either group at the time of the analysis.

Who was included in the VOLGA trial?

VOLGA was a randomized, open-label trial that enrolled 695 people with MIBC. Randomized means patients were assigned to groups by chance. Open-label means patients and their doctors knew which treatment each patient received. Patients were split evenly into three groups: Imfinzi plus Padcev before and after surgery, surgery alone, or a different investigational treatment combination.

How is Imfinzi plus Padcev given for bladder cancer?

Before surgery, patients weighing 30 kg (about 66 pounds) or more receive 1,500 mg of Imfinzi every three weeks. They also receive Padcev at 1.25 mg/kg on days 1 and 8 of each cycle, for three cycles. After surgery, they receive 1,500 mg of Imfinzi alone every four weeks for up to nine cycles. Patients weighing less than 30 kg receive Imfinzi at 20 mg/kg on the same schedules.

Treatment continues until the cancer progresses so that surgery is no longer possible, the cancer comes back, side effects become too difficult to manage, or patients finish the nine cycles after surgery.

What side effects were reported with Imfinzi plus Padcev?

The most common side effects, reported in more than 20% of patients, included:

  • changes in blood tests, including higher liver enzymes (AST and ALT), creatinine (a marker of kidney function), the pancreatic enzymes lipase and amylase, potassium and alkaline phosphatase
  • lower hemoglobin, calcium, sodium and white blood cell counts
  • rash and itching
  • urinary tract infection
  • fatigue, diarrhea, constipation, nausea and decreased appetite
  • changes in taste
  • nerve damage that causes numbness or tingling (peripheral neuropathy)
  • muscle and bone pain
  • hair loss

Imfinzi’s prescribing information includes warnings about:

  • immune-related side effects, which happen when the immune system attacks healthy organs
  • infusion-related reactions
  • complications for patients who receive a stem cell transplant from a donor
  • harm to an unborn baby

Patients should talk with their care team about the possible benefits and risks of this treatment.

Reference

  1. “FDA Approves Durvalumab With Enfortumab Vedotin-ejfv for Muscle-Invasive Bladder Cancer.” U.S. Food and Drug Administration. Nov. 13, 2026.

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