Sesen said in a statement the FDA gave the designation for the drug Vicinium to treat high-grade non-muscle invasive bladder cancer. The drug is its lead candidate and is being evaluated in a Phase 3 registration trial. The fast-track approval gives the drug expedited development and review because they are used for life-threatening conditions and fill an unmet medical need.
The company expects to top-line results by the middle of 2019.
Shares of Sesen on Nasdaq were up 15.6% to US$1.78. The stock traded as high as US$1.85.
Sesen said it believes that Vicinium’s cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs.
The Cambridge, Massachusetts, company develops next-generation treatments for cancer.