Vicinium, a potential treatment for bacillus Calmette-Guérin-unresponsive high-grade non-muscle invasive bladder cancer (NMIBC), has been granted Fast Track designation by the Food and Drug Administration (FDA). 

Vicinium is being developed by Sesen Bio through their proprietary Targeted Protein Therapeutics platform. It is an antibody-drug conjugate comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells. Once bound to the EpCAM antigen on the surface of carcinoma cells, Vicinium is internalized through an endocytic pathway and induces cell death by irreversibly blocking protein synthesis.

A Phase 3 trial (VISTA) of the treatment is currently taking place. The trial is evaluating the treatment in patients with NMIBC who have previously received 2 courses of BCG and who are now BCG-unresponsive. 

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“We are highly encouraged by the differentiated product profile of Vicinium in NMIBC, with a unique mechanism of action, positive 3-month data presented earlier this year and favorable tolerability in patients treated to-date,” said Dr Thomas Cannell, president and chief executive officer of Sesen Bio.

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