FDA Grants Accelerated Approval to Pfizer's PADCEV for Bladder Cancer Treatment

The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Pfizer's PADCEV® (enfortumab vedotin) in combination with Keytruda® (pembrolizumab). This approval is for patients with locally advanced or metastatic, non-muscle-invasive bladder cancer who have previously received platinum-based chemotherapy and either a PD-1 or PD-L1 inhibitor, or who are not eligible for cisplatin-based chemotherapy.

Recenlty, the combination also received FDA Priority Review for the treatment of metastatic prostate cancer, signaling a potential expansion of its use. This latest approval offers a new treatment avenue for a patient population with limited options.

PADCEV® is an antibody-drug conjugate that targets Nectin-4, a protein often found on cancer cells. When used with Keytruda®, an immunotherapy agent, the combination aims to improve treatment response and patient outcomes. Pfizer developed PADCEV® in collaboration with Astellas Pharma Inc.