Europe expands Keytruda-Padcev use in bladder cancer after 47% reduction in risk of disease progression or death
Key Facts
Merck announced on October 21, 2026, that the European Commission had approved expanded use of Keytruda with Padcev to treat adults with resectable muscle-invasive bladder cancer. The decision covers use of the combination before surgery and after radical cystectomy, according to the company's statement. It extends treatment to patients "regardless of cisplatin eligibility," Merck said, broadening the population covered by the European approval. Muscle-invasive bladder cancer means the disease has spread into the muscular wall of the bladder, according to the U.S. National Cancer Institute. The previous European approval for this use before and after surgery was limited to patients ineligible for cisplatin.
The expansion was based on a study involving 808 patients, randomly assigned in a 1:1 ratio to the combination plus surgery or chemotherapy before surgery followed by surgery, according to Merck. The combination reduced the risk of disease progression, recurrence or death by 47% compared with gemcitabine and cisplatin before surgery followed by surgery in cisplatin-eligible patients. The hazard ratio for this measure was 0.53, according to results the company announced in support of the European expansion. The risk of death also fell by 35% compared with chemotherapy before surgery followed by surgery in this patient group. The pathological complete response rate was 55.8% with the combination, compared with 32.5% among patients receiving chemotherapy before surgery.
On safety, Astellas said adverse events of grade 3 or higher, from any cause, were reported in 75.7% of patients receiving the combination before and after surgery in the study. Keytruda is a Merck drug, while Padcev is a Seagen and Astellas drug, according to Astellas' statement on the treatment. Development of the combination used to treat bladder cancer stemmed from a clinical collaboration between Merck, Seagen and Astellas. Padcev belongs to a class of drugs that link a monoclonal antibody to a drug that kills cancer cells, according to the U.S. National Cancer Institute. After the compound enters the cells, the drug stops them from dividing and causes them to die, according to the institute's description of its mechanism of action.
Merck announced the previous European approval for treatment before and after surgery on June 24, 2026. In the study supporting that approval, the combination was compared with surgery alone in patients ineligible for cisplatin. The treatment reduced the risk of disease progression, recurrence or death by 60% compared with surgery alone, according to the company's statement at the time. It also reduced the risk of death by 50% in the same study. That followed Merck's announcement on September 3, 2024, of European approval for the combination as a first-line treatment for adults with unresectable or metastatic urothelial cancer.
These regulatory developments come as Merck reported combined sales of Keytruda and Keytruda Qlex of $8.4 billion in the second quarter of 2026. Reported sales rose 5% compared with the second quarter of 2025, according to the company's results. Growth was 4% excluding the impact of currency fluctuations over the same period. Merck attributed sales growth for the Keytruda family primarily to strong global uptake in early-stage indications, including bladder cancer. The company said higher demand for the drug in metastatic indications also contributed to sales growth.
In the United States, the Food and Drug Administration approved the combination on November 21, 2025, for use before and after cystectomy in patients ineligible for cisplatin. The U.S. agency then expanded the approval on July 10, 2026, to include patients eligible for surgery regardless of cisplatin eligibility. Under that U.S. decision, the expanded use covers treatment before and after cystectomy. In Europe, Merck said the timing of commercial availability in each country depends, among other factors, on completion of national reimbursement procedures. The company will hold its third-quarter 2026 earnings call on October 29, 2026, at 9 a.m. U.S. Eastern Time.