9 August 2018 - Sesen Bio today announced that the U.S. FDA has granted fast track designation to Vicinium for the treatment of BCG-unresponsive high-grade non-muscle invasive bladder cancer.

Vicinium, Sesen Bio’s lead product candidate, is currently being evaluated in a Phase 3 registration trial, the VISTA Trial, for the treatment of patients with high-grade non-muscle invasive bladder cancer who have previously received two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive.

Enrollment is complete in the Phase 3 VISTA Trial and the company expects to report 12-month efficacy results in mid-2019.

Read Sesen Bio press release