Avenzo Therapeutics granted Fast Track Designation for AVZO-103, a potential best-in-class nectin4/TROP2 bispecific ADC, for the treatment of patients with urothelial cancer previously treated with enfortumab vedotin

CAR-T Digest - August 2020

Weekly Digest - November 2025

24 November 2025: Avenzo Therapeutics granted Fast Track Designation for AVZO-103, a potential best-in-class nectin4/TROP2 bispecific ADC, for the treatment of patients with urothelial cancer previously treated with enfortumab vedotin

The FDA has granted Fast Track designation to AVZO-103, Avenzo Therapeutics’ Nectin4/TROP2 bispecific antibody-drug conjugate, for urothelial cancer patients previously treated with enfortumab vedotin
AVZO-103 targets a population with no currently approved ADC options after enfortumab vedotin failure, representing a significant unmet medical need
Avenzo highlights AVZO-103 as a potential best-in-class therapy and emphasizes its commitment to accelerating development for these hard-to-treat patients
The Fast Track status is expected to support faster review processes and facilitate more frequent interactions with the FDA
AVZO-103 is being evaluated in an ongoing Phase 1/2 first-in-human study assessing its safety, tolerability, and early clinical activity as monotherapy and in combination regimens for advanced solid tumors