For decades, patients with muscle-invasive bladder cancer faced a grim reality: the same chemotherapy treatment, unchanged since the 1990s. Now, a major international study is changing that story — and giving thousands of patients a real reason for hope.
Researchers found that a two-drug combination — enfortumab vedotin and pembrolizumab — helps bladder cancer patients live longer while dramatically cutting the odds their cancer will return after surgery. The phase 3 clinical trial, published in the New England Journal of Medicine, enrolled 808 patients at 158 hospitals and cancer centers around the world.
Bladder cancer is the sixth most common cancer in the United States, with nearly 85,000 Americans expected to be diagnosed this year alone. About one in four cases are "muscle-invasive" — a more aggressive form that spreads easily and often returns after treatment.
The study was led by Dr. Matthew D. Galsky, a bladder cancer expert and professor at the Icahn School of Medicine at Mount Sinai in New York. He explained that patients have relied on the same presurgery chemotherapy for more than twenty years — until now.
The results were striking. Two years after starting treatment, nearly 80% of patients who received the newer drug combination remained free of cancer progression, recurrence, or death. That compares to just 66% of patients on the old standard chemotherapy. Patients on the new treatment also had a 47% lower risk of their cancer coming back or spreading.
Perhaps most remarkably, more than half of patients receiving the new combination had no detectable cancer in their surgical tissue — compared to only about one-third of those on standard chemotherapy.
"This study demonstrates that enfortumab vedotin and pembrolizumab can provide better outcomes than standard cisplatin-based chemotherapy, reducing the risk that cancer will return or spread after surgery," said Dr. Galsky. "These findings represent a major step forward and are likely to change the standard of care for patients around the world."
On July 10, 2026, the Food and Drug Administration officially approved this combination as a treatment option for all eligible patients with muscle-invasive bladder cancer — expanding access beyond the narrower group studied earlier.
The researchers note that the new treatment does come with more side effects than chemotherapy, which means patients need careful monitoring by experienced cancer care teams. But for many patients and their families, the chance of a cure makes that trade-off worthwhile.
"Our goal is to give more patients the chance for long-term survival and potentially cure their disease," said Dr. Galsky.