Padcev and Keytruda combination expands bladder cancer approval
The FDA approved an expanded indication for the combination of Padcev and Keytruda, making it the first perioperative treatment for muscle-invasive bladder cancer that can be used regardless of a patient’s eligibility for cisplatin chemotherapy. The approval was based on Phase 3 data showing improvements in event-free and overall survival compared with standard treatment.
Discovered by Seattle-based Seagen, now part of Pfizer, Padcev has become a foundational therapy for urothelial and bladder cancers. The expanded approval allows it to be used earlier in treatment, giving more patients access to the combination before and after surgery.
The approval highlights the continued impact of Washington-developed cancer therapies and reflects the state’s leadership in oncology research and drug development.