Samsung Bioepis wins FDA Fast Track for anticancer drug candidate
In short
- The FDA granted Fast Track designation to SBE303, an anticancer drug candidate, the company said.
- SBE303 targets Nectin-4, a protein found in urothelial, lung and breast cancers.
- It pairs a Nectin-4 antibody with a topoisomerase I inhibitor, aiming to widen the safe dose range.
Why the Good News Desk likes this one
Existing Nectin-4 targeted drugs have a narrow gap between an effective dose and a harmful one. SBE303 is designed to widen that gap by using its own linker and a potent anticancer agent. Fast Track status speeds regulatory review, but SBE303 is still a candidate, not an approved treatment.
From The Korea Times
Samsung Bioepis has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for SBE303, an anticancer drug candidate based on antibody-drug conjugate (ADC) technology, the company said Wednesday. SBE303 is the first novel drug candidate in Samsung Bioepis' pipeline. It is an ADC, a type of biopharmaceutical drug designed to deliver powerful cancer-killing agents directly to cancer cells while minimizing damage to healthy tissues. ADCs are oftentimes referred to as "biological missiles" because of their targeted approach. SBE303 targets Nectin-4, a cell adhesion...
