Samsung Bioepis, a subsidiary of Samsung Epis Holdings, said that its anticancer new drug candidate 'SBE303' has been designated as a 'Fast Track' drug by the U.S. Food and Drug Administration (FDA).
SBE303 is an ADC (antibody-drug conjugate) therapy targeting 'Nectin-4,' a protein overexpressed in tumor cells, and represents the first new drug pipeline being developed by Samsung Bioepis.
This Fast Track designation targets the treatment of patients with locally advanced or metastatic urothelial carcinoma who have previously received existing Nectin-4-targeting therapies.
The U.S. FDA's Fast Track program designates drugs that show potential for treating severe diseases where existing treatments are limited, selected from new drug candidates whose efficacy has been confirmed in early animal trials and other studies.
The greatest advantage is cited as the expansion of direct communication opportunities with regulatory authorities. Accordingly, Samsung Bioepis has secured opportunities for more refined risk management and process control from the early stages of SBE303 development.
Jung Byung-in, head of the RA Team at Samsung Bioepis, said, "The U.S. FDA's Fast Track drug designation is a result of recognizing the potential value of SBE303 in addressing unmet medical needs as a therapy for severe diseases," adding, "This has proven that Samsung Bioepis possesses global-level research and development capabilities in new drug development."
in THEBIO
