The European Commission is expected to issue a final ruling by the fourth quarter of 2026.
On 18 September 2026, Merck received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for Keytruda combined with Padcev. The committee backed the regimen as a perioperative therapy for adults with resectable muscle-invasive bladder cancer across the European Union.
If endorsed by the European Commission, the combination would be the first PD-1 inhibitor and antibody-drug conjugate option for this setting in Europe. The final ruling from the European Commission is expected by the fourth quarter of 2026.
The potential patient population represents an area of high clinical need. European bladder cancer cases were estimated at about 224,700 in 2022, with roughly 25% classified as muscle-invasive. Many of those patients either recur after cisplatin and surgery or never receive cisplatin.
Merck holds a reported market value of about $363.0 billion and has more than 20 planned growth drivers in development. Expanding Keytruda and Padcev into earlier cancer stages supports the company's broader effort to deepen its late-stage pipeline ahead of Keytruda's eventual loss of exclusivity.
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