Samsung Bioepis said the FDA has granted Fast Track designation to SBE303, its first antibody-drug conjugate candidate, for certain patients with advanced urothelial cancer.
The designation covers locally advanced or metastatic disease in patients previously treated with enfortumab vedotin. SBE303 remains investigational and is undergoing Phase 1 clinical development.
Fast Track status is intended to support development and review of medicines for serious or life-threatening conditions with unmet medical needs. It allows more frequent discussions with the FDA and eligibility for rolling review.
The candidate could also qualify for Priority Review or Accelerated Approval if it meets the separate requirements for those pathways. Fast Track designation itself does not constitute approval.
SBE303 targets Nectin-4, an adhesion protein expressed in several tumor types, including urothelial, lung and breast cancers. It combines an antibody directed at that protein with a topoisomerase I inhibitor, connected through a proprietary linker.
Samsung Bioepis said the drug was designed to improve the therapeutic window, balancing anticancer activity against toxicity. The company noted that existing Nectin-4-targeting antibody-drug conjugates can be constrained by dose-limiting adverse effects.
The announcement did not include patient response data, safety findings, enrollment figures or a timetable for completing the Phase 1 study.
Byoungin Jung, the company’s vice president and regulatory affairs team leader, said the designation would enable closer dialogue with the FDA as the global trial progresses.
The study is registered under identifier NCT07524348.
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