FDA approves Padcev and Keytruda combo for advanced bladder cancer

The US Food and Drug Administration (FDA) on Friday granted full approval for Padcev (enfortumab vedotin-ejfv, an antibody-drug conjugate [ADC]) with Keytruda (pembrolizumab, a PD-1 inhibitor) for the treatment of adult patients with locally-advanced or metastatic urothelial cancer (la/mUC).

Padcev was developed by Seagen, now a part of US pharma giant Pfizer (NYSE: PFE), and is the subject of a licensing deal with Japan’s Astellas Pharma (TYO: 4503). Keytruda is a mega-blockbuster cancer drug marketed by Merck & Co (NYSE: MRK).

This combination is the first approved to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC. The bladder cancer drug market is forecast to reach a value of $5.6 billion in 2028, according to Global Data.