An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
Latest Information Update: 25 Sep 2024
At a glance
- Drugs Enfortumab vedotin (Primary) ; Docetaxel; Paclitaxel; Vinflunine
- Indications Bladder cancer; Carcinoma; Pelvic cancer; Renal cancer; Squamous cell cancer; Ureteral neoplasms; Urethral cancer; Urogenital cancer
- Focus Registrational; Therapeutic Use
- Acronyms EV-301
- Sponsors Astellas Pharma Global Development
- 19 Sep 2024 Planned End Date changed from 31 Aug 2024 to 28 Feb 2025.
- 19 Aug 2024 According to an Astellas Pharma media release, the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved PADCEV™ (enfortumab vedotin) for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
- 01 Jun 2024 Results assessing patient experiences of EV versus chemotherapy using patient-reported outcome (PRO) analysis of health-related quality of life published in the European Urology