Samsung Bioepis’ First Novel Drug Candidate SBE303 Granted U.S. FDA Fast Track Designation

[Financial News] Samsung Bioepis’ first novel drug candidate under development has received Fast Track designation from the U.S. Food and Drug Administration (FDA). The designation recognizes its potential to address unmet medical needs in serious diseases for which existing treatments have limitations, and provides a basis for close consultation with the FDA during development.
 Samsung Bioepis said on the 21st that its anticancer drug candidate SBE303 had been designated a Fast Track drug by the FDA. The designation is for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have previously received a Nectin-4-targeted therapy.
 SBE303 is an antibody-drug conjugate (ADC) therapy that targets Nectin-4, a protein highly expressed in cancer cells. ADCs deliver drugs to cancer cells by linking anticancer drugs to antibodies that seek out those cells. SBE303 is Samsung Bioepis’ first novel drug candidate under development.
 The FDA Fast Track program supports the development and review of new drugs that may address unmet medical needs while treating serious diseases. Designated drugs can receive more frequent consultation with the FDA during development and exchange views on matters such as clinical trial design and required data.
 The drug may also qualify for “Rolling Review,” under which completed portions of a marketing application are submitted for review as they become ready. This can reduce regulatory uncertainty during development and help make the review process more efficient later on. However, Fast Track designation itself does not establish clinical efficacy or safety, nor does it guarantee drug approval. 
 Samsung Bioepis expects the designation to enable it to communicate with the FDA from the early stages of development, assess risks in the development process, and manage related procedures.
 Jeong Byeong-in, executive director and head of the Regulatory Affairs (RA) team at Samsung Bioepis, said, “The FDA’s Fast Track designation reflects recognition of SBE303’s potential to address unmet medical needs as a treatment for serious diseases. This will enable us to demonstrate that we have globally competitive R&D capabilities in new drug development as well.”

[email protected] Jeong Sang-hee Reporter