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Weekly Digest - October 2026
21 October 2026: Samsung Bioepis receives FDA FTD for SBE303 for the treatment of Urothelial cancer
- Samsung Bioepis announced that the U.S. FDA has granted Fast Track Designation to SBE303, its first investigational antibody-drug conjugate, for patients with locally advanced or metastatic urothelial cancer who have previously received enfortumab vedotin
- The designation supports accelerated development of SBE303, which is currently being evaluated in a global phase 1 clinical trial to assess its safety, tolerability and preliminary antitumor activity. The program remains in early clinical development, with clinical efficacy yet to be established
- The designation addresses an unmet need in advanced urothelial cancer following enfortumab vedotin treatment, where disease progression and treatment-related toxicities can limit subsequent options and additional therapies are needed
- SBE303 is a Nectin-4-directed ADC comprising a highly specific anti-Nectin-4 antibody linked to a novel topoisomerase I inhibitor payload through a proprietary linker, designed to improve the therapeutic window and address limitations associated with existing Nectin-4-targeted ADCs
- Strategically, the Fast Track Designation strengthens Samsung Bioepis’ entry into novel ADC development beyond its biosimilar portfolio. SBE303’s continued clinical advancement could position the company in the post-enfortumab urothelial cancer setting while supporting its broader oncology pipeline expansion
