Viniceum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for treatment of BCG-unresponsive non-muscle invasive bladder cancer. The company is currently in the follow-up stage of a Phase 3 registration trial in the U.S. for the drug.
BCG refers to Bacillus Calmette-Guerin and is the most common intravesical immunotherapy for treating early-stage bladder cancer.
In February, the FDA accepted the company’s biologics license application file for Viniceum and granted application priority review with a target Prescription Drug User Fee Act date of Aug. 18.
The American Cancer Society estimates there will be about 83,730 new cases of bladder cancer in 2021, with 17,200 deaths. Bladder cancer is the fourth most common cancer in men, but it’s less common in women, the society said.
Vicineum’s activity in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s (AZN Get Report immune checkpoint inhibitor durvalumab, the company said in an earlier statement.
On Monday, Sesen Bio posted a wider-than-expected second-quarter loss and missed revenue expectations.
