A cancer drug candidate from Samsung Bioepis, a unit of Samsung Epis Holdings (0126Z0), has been granted Fast Track designation by the U.S. Food and Drug Administration.
Samsung Bioepis said on Oct. 21 that its cancer drug candidate SBE303 had received Fast Track designation from the FDA. SBE303 is an antibody-drug conjugate, or ADC, that targets Nectin-4, a protein overexpressed in tumor cells. It is the first novel drug in Samsung Bioepis' development pipeline.
Under the FDA's Fast Track program, the agency selects drug candidates that have shown efficacy in early studies such as animal testing and that have the potential to treat serious conditions for which existing therapies fall short. The designation covers treatment of patients with locally advanced or metastatic urothelial cancer who have previously received a Nectin-4-targeting therapy.
The biggest advantage of Fast Track designation is seen as the expanded opportunity for direct communication with regulators. As a result, Samsung Bioepis will be able to manage risks and development processes more closely from the early stages of SBE303's development.
Jung Byung-in, vice president and head of the regulatory affairs team at Samsung Bioepis, said the FDA's Fast Track designation reflects recognition of SBE303's potential value in addressing unmet medical needs as a treatment for serious disease. "Through this, we can demonstrate that we have global-level research and development capabilities in novel drug development as well," the executive stressed.