FDA grants Fast Track status to Samsung Bioepis’ SBE303 — Korea Herald

In the United States, the Food and Drug Administration (FDA) has granted Fast Track status to Samsung Bioepis’ SBE303 drug candidate. It is the company’s first candidate being developed as an original medicinal product. Korea Herald reports.

Candidate for treating urothelial cancer

SBE303 is an antibody-drug conjugate (ADC) targeting the Nectin-4 protein. According to Samsung Bioepis, this protein is overexpressed on tumor cells.

The candidate is being developed to treat patients with locally advanced or metastatic urothelial cancer who previously received Nectin-4-targeted therapy.

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Interaction with the regulator

Fast Track status is intended to accelerate the development and review of medicines for serious diseases with unmet medical needs. It allows developers to communicate more frequently with the FDA and discuss development plans and regulatory requirements earlier.

Samsung Bioepis said the status is expected to help identify and address potential development risks and manage the regulatory process more thoroughly at an early stage. A global Phase 1 clinical trial of SBE303 is ongoing. The development of the candidate also represents an expansion of the company’s operations beyond its established biosimilars business.