Sesen Bio To Conduct Additional Trial For Potential Resubmission Of Vicineum In Bladder Cancer
- Sesen Bio Inc (NASDAQ: 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.
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