Celltrion ADC drug candidate CT-P71 receives FDA Fast Track Designation for urothelial carcinoma

CAR-T Digest - August 2020

09 April 2026: Celltrion ADC drug candidate CT-P71 receives FDA Fast Track Designation for urothelial carcinoma

Celltrion’s ADC candidate CT-P71 has received FDA Fast Track Designation for the treatment of previously treated locally advanced or metastatic urothelial carcinoma, addressing a high unmet need
This marks the company’s second Fast Track Designation, following CT-P70 in NSCLC, highlighting growing recognition of its ADC pipeline in difficult-to-treat cancers
The candidate is currently in Phase 1 clinical development in solid tumors (including urothelial cancer), with early progress supporting its potential as a best-in-class therapy, including activity in resistance models
CT-P71 is a Nectin-4 targeting ADC, designed to improve upon existing therapies, and has shown strong anti-tumor activity and superior safety in preclinical studies compared to enfortumab vedotin
With Fast Track Designation enabling closer FDA interaction, rolling review, and potential priority pathways, CT-P71 is now positioned for more efficient clinical development and a potentially faster path to approval