Sesen Bio To Conduct Additional Trial For Potential Resubmission Of Vicineum In Bladder Cancer

Sesen Bio Inc SESN has outlined its anticipated regulatory path forward for Vicineum for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) following its Clinical Type A meeting with the FDA.
Following the meeting, the Company has agreed to conduct a randomized clinical trial assessing the safety and efficacy of Vicineum compared to investigators' choice of intravesical chemotherapy.
The trial may include both patients who have received adequate BCG and patients who have received less-than-adequate BCG;
The anticipated randomized trial design aligns with guidance from the European Medicines Agency, which may help coordinate the regulatory paths forward for Vicineum in the US and the European Union.
The Company expects to hold a Type C meeting with the FDA in early 2022 to discuss the protocol for the additional clinical trial.
Also Read: Sesen Bio's Bladder Cancer Trial Wrecked By Misconduct: Stat News.
Price Action: SESN shares are down 17.40% at $0.89 during the market session on the last check Thursday.