FDA grants fast track to Samsung Bioepis ADC candidate SBE303

Samsung Bioepis said its first proprietary drug candidate, SBE303, received FDA fast track designation. The ADC targets Nectin-4 and is intended for patients with locally advanced or metastatic urothelial cancer previously treated with a Nectin-4 therapy. The status speeds development and increases interaction with regulators.

• SBE303 is an ADC targeting the Nectin-4 protein
• Indication is urothelial cancer after Nectin-4 therapy
• Fast track speeds development and FDA dialogue
• It is Samsung Bioepis's first proprietary drug pipeline