New First-Line Treatment for Bladder Cancer Approved by FDA

Americans with local advanced or metastatic bladder cancer can now turn to a new first-line treatment for their disease—a drug combination that shows better outcomes compared to chemotherapy. The FDA approved the combination of enfortumab vedotin-ejfv (Padcev) and pembrolizumab (Keytruda) for patients, regardless of their cisplatin eligibility, following a study showing its efficacy. The combination previously received accelerated FDA approval for patients who could not receive cisplatin-containing chemotherapy. “[The] FDA approval represents a paradigm change in the treatment of advanced bladder cancer and provides hope to the thousands of Americans impacted by this aggressive disease,” said Dr. Ahsan Arozullah, senior vice president and head of oncology development for Astellas, in a press release on Dec. 15. “This achievement is notable, as it is the first regimen approved in advanced urothelial cancer that has demonstrated superiority to platinum chemotherapy, the gold standard of care for decades.”...