The treatment, combining enfortumab vedotin and pembrolizumab, marks the first significant advance in care for this condition since the 1980s.
Clinical trials showed the new therapy doubles patients' average survival time to 33.8 months, compared to 15.9 months with chemotherapy.
Approximately 1,250 people in England each year are estimated to benefit from this treatment, which also improves progression-free survival and complete response rates.
Experts and patient advocates have welcomed the approval, highlighting its potential to fundamentally reshape care and significantly improve the lives of those affected.