Health · Pharma & Biotech · 2 hrs ago
FDA grants fast-track status to Samsung Bioepis cancer drug candidate
Samsung Bioepis’ SBE303 received FDA fast-track designation in the United States.
The company is a subsidiary of Samsung Epis Holdings, and SBE303 is its first drug candidate.
It is an antibody-drug conjugate, a type of cancer drug.
The designation covers people with locally advanced or metastatic urothelial cancer who have already received a nectin-4-targeted treatment.
The FDA’s fast-track designation is intended to expedite the drug’s development and review.
The information provided does not say what the next development step will be.
The US Food and Drug Administration granted fast-track designation to Samsung Bioepis’ cancer drug candidate SBE303.
SBE303 is an antibody-drug conjugate, or ADC.
The designation covers patients with locally advanced or metastatic urothelial cancer who have received an existing nectin-4-targeted treatment.
Samsung Bioepis said it received the designation on Oct. 21.
SBE303 is Samsung Bioepis’ first new drug candidate.
- Who
- Samsung Bioepis and the US Food and Drug Administration.
- What
- The FDA granted fast-track designation to SBE303, an ADC cancer drug candidate.
- When
- Samsung Bioepis said on Oct. 21, 2026, that the drug received the designation.
- Where
- The United States.
- Why
- The designation applies to patients with locally advanced or metastatic urothelial cancer previously treated with a nectin-4-targeted therapy. The reason for the FDA’s decision was not stated.
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This story does not have a timeline yet.
- Drug candidate
- SBE303
- Drug type
- Antibody-drug conjugate (ADC)
- Designation
- FDA fast-track
- Eligible patients
- Locally advanced or metastatic urothelial cancer after nectin-4-targeted treatment
- Company milestone
- Samsung Bioepis’ first new drug candidate