Samsung Bioepis Secures FDA Fast Track Status for First ADC Cancer Candidate

Samsung Bioepis disclosed that the U.S. Food and Drug Administration has assigned Fast Track designation to SBE303, the firm’s first novel anticancer drug candidate. SBE303 is an antibody-drug conjugate that directs a topoisomerase I inhibitor to cells expressing the Nectin-4 protein, which is common in several solid tumors including urothelial, lung and breast cancers. Existing Nectin-4-targeted ADCs suffer from a narrow therapeutic window, but Samsung Bioepis’ proprietary linker technology is intended to mitigate this limitation.

The drug is currently undergoing Phase 1 clinical testing. Fast Track status speeds development and review, and may qualify SBE303 for rolling, priority or accelerated approval if criteria are satisfied. Vice President Jung Byoung-in highlighted the unmet need in advanced solid tumors and the regulatory benefits of the designation.