US authorities' designation establishes regulatory framework for Korean drugmaker
Samsung Bioepis said Wednesday that its first antibody-drug conjugate, or ADC, candidate has been designated a Fast Track drug by the US Food and Drug Administration.
According to Samsung Bioepis, SBE303 is designed to target Nectin-4, a protein overexpressed on tumor cells. The candidate is being developed as a treatment for patients with locally advanced or metastatic urothelial cancer who have previously received a Nectin-4-targeted therapy.
The FDA's Fast Track designation is intended to expedite the development and review of drugs for serious conditions that address unmet medical needs, meaning it can offer drugmakers more frequent communication with the regulator as well as opportunities to discuss development plans and regulatory requirements earlier.
For Samsung Bioepis, the designation is expected to help the company identify and address potential development risks and manage the regulatory process more closely as SBE303 advances through early-stage development.
SBE303 is Samsung Bioepis' first drug candidate developed as a novel medicine, marking an expansion beyond the company's established biosimilar business.
"The FDA’s Fast Track designation for SBE303 reflects the critical unmet medical need in patients with advanced solid tumors and recognizes the therapeutic rationale of targeting Nectin-4 with our next-generation ADC candidate,” said Jung Byoung-in, vice president at Samsung Bioepis.
“This designation establishes an important regulatory framework for our program, enabling closer dialogue and more frequent interactions with the Agency as our global Phase 1 study advances. We look forward to working collaboratively with the FDA to guide our clinical development program efficiently and advance SBE303 through each stage of evaluation."
hwkan@heraldcorp.com