Samsung Bioepis SBE303 receives US FDA Fast Track designation

Samsung Bioepis has announced that its first novel drug candidate, SBE303, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA).

SBE303 is an antibody-drug conjugate (ADC) designed to target Nectin-4, a protein that is overexpressed in certain tumor cells. The designation specifically applies to the treatment of locally advanced or metastatic urothelial carcinoma in patients who have previously received Nectin-4 targeted therapies.

The FDA Fast Track program is intended for drugs that show potential to address unmet medical needs for serious conditions. This designation provides Samsung Bioepis with increased opportunities for direct communication with regulatory authorities, allowing for more efficient clinical design and proactive risk management during the early stages of development.