Merck’s Keytruda expands again as FDA approves Padcev pairing before and after surgery in bladder cancer.

Here’s the episode-ready breakdown based on today’s FDA approval of PADCEV (enfortumab vedotin, an ADC) plus KEYTRUDA / KEYTRUDA QLEX (pembrolizumab, PD-1 inhibitor) as perioperative treatment for cisplatin-ineligible muscle-invasive bladder cancer, a first-of-its-kind ADC + PD-1 regimen showing meaningful survival and pathologic response benefits.

WINNERS -

Category 1: Bladder cancer combo owners and near-term revenue beneficiaries

Reason: This approval expands use of an already blockbuster PD-1 (KEYTRUDA) into a new perioperative MIBC population and locks in a new standard of care pairing with an ADC (PADCEV), directly widening addressable patients and treatment duration. Trial data showed major improve ...