This regulatory milestone follows a priority review granted by the agency in April. Previously, the combination was restricted to patients unable to tolerate cisplatin, a common but taxing chemotherapy regimen. By removing this barrier, the FDA allows clinicians to utilize the Keytruda-Padcev pairing for a wider demographic of adults battling muscle-invasive forms of the disease.

Marjorie Green, head of oncology at Merck Research Laboratories, framed the development as a significant advancement for perioperative care. The companies began their collaborative efforts in 2019, eventually pairing the immunotherapy Keytruda with the antibody-drug conjugate Padcev. The latter was developed by Astellas and Seagen, the latter of which became a Pfizer subsidiary following a $43 billion acquisition last year.