Samsung Bioepis says FDA granted Fast Track status to cancer drug candidate SBE303

Samsung Bioepis said on October 21 that the US Food and Drug Administration had granted Fast Track designation to SBE303, its first novel drug candidate. The designation concerns development of the cancer treatment for patients with locally advanced or metastatic urothelial cancer who have already received a therapy targeting Nectin-4; it gives the company more opportunities to consult regulators while the drug is in an early clinical trial.

Who SBE303 is being developed to treat

SBE303 is an antibody-drug conjugate, a treatment designed to carry a cancer-fighting drug to cells through an antibody. Samsung Bioepis says it targets Nectin-4, a protein overexpressed on tumor cells. The Fast Track designation covers a defined group of urothelial cancer patients whose disease is locally advanced or has spread and who have previously received a Nectin-4-targeted treatment.

What FDA Fast Track changes

The FDA's Fast Track programme is intended to help develop and review medicines for serious conditions with unmet medical needs. It provides more frequent communication with the regulator and opportunities to discuss development plans and regulatory requirements earlier. For Samsung Bioepis, that could help identify issues as SBE303 proceeds through clinical development, but the designation is not approval to market the drug or evidence that it works in patients.

Jung said the designation recognised the therapeutic rationale for targeting Nectin-4 and the unmet need among patients with advanced solid tumours. His remarks describe the company's case for continuing development; the treatment's safety and effectiveness remain to be established in clinical testing.