The US Food and Drug Administration (FDA) has expanded the approved indication for the Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) combination, allowing its use in a broader population of patients with muscle-invasive bladder cancer (MIBC).

The updated approval extends the combination beyond advanced disease, enabling eligible patients to receive the therapy in the perioperative setting. The decision is supported by clinical evidence demonstrating improved outcomes compared with standard treatment, reinforcing the growing role of antibody-drug conjugate and immunotherapy combinations in earlier stages of bladder cancer.

The expanded indication marks another milestone for Astellas Pharma and Pfizer, strengthening the companies' oncology portfolios while offering clinicians an additional treatment option for patients with high-risk bladder cancer. The approval also reflects the continued shift towards integrating targeted therapies and immuno-oncology earlier in the cancer treatment pathway.