Vicineum has been awarded a priority review for patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC). Under the Prescription Drug User Fee Act (PDUFA), the target date for the FDA’s decision on the therapy’s biologics license application (BLA) is August 18, 2021. The FDA will not hold an advisory committee meeting to discuss vicineum’s BLA, according to Sesen Bio, the agent’s developer.1

Vicineum comprises a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A, which obstructs protein synthesis. Radical cystectomy is recommended for patients with NMIBC who cannot receive further BCG therapy or for whom BCG is not effective. Sensen Bio maintains that vicineum could be a viable nonsurgical alternative to radical cystectomy in this subpopulation.2

The locally administered agent is the therapeutic focus of the ongoing phase 3 VISTA study (NCT02449239). VISTA investigators are studying vicineum’s activity in patients with NMIBC who previously received standard-of-care BCG.3

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The primary end point of the single-arm study is the complete response rate. Secondary end points include the recurrence rate, event-free survival, and the number of patients with adverse events as a measure of tolerability, among other secondary outcomes measures.


  1. Sesen Bio announces FDA acceptance and priority review of its biologics license application for Vicineum™. [press release]. Cambridge, MA: Sensen Bio; February 16, 2021.
  2. Our Programs. Sensen Bio. Updated 2021.
  3. Vicinium treatment for subjects with non-muscle invasive bladder cancer previously treated with BCG. NCT02449239. Accessed February 17, 2021.