The FDA is expected to decide whether or not to approve Sesen Bio Inc.’s (SESN) Vicineum on August 18.Vicineum is proposed for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).Bladder cancer is the 6th most prevalent cancer in the US, of which 75%-85% is NMIBC.Vicineum, if approved, could face competition from Valstar, relaunched in 2009, and Merck’s Keytruda, approved for BCG-unresponsive, high-risk non-muscle invasive bladder cancer in January 2020.According to the company, Vicineum has the potential to achieve peak global sales in the range of $1 billion to $3 billion.The European Medicines Agency is also reviewing Vicineum, and if approved, the drug will be launched under the brand name Vysyneum. The company remains on-track for potential approval of Vysyneum in the European Union in early 2022.Enzon Pharmaceuticals Inc. (ENZN.OB) is entitled to a share of certain milestone and royalty payments if Vicineum is approved for the treatment of non-muscle invasive bladder cancer.SESN closed Monday’s (Jul.26, 2021) trading at $3.75, down 2.85%.