Following FDA meeting a new phase III trial is planned for Vicineum for the treatment of NMIBC
Following FDA meeting a new phase III trial is planned for Vicineum for the treatment of NMIBC (non-muscle invasive bladder cancer)
After meeting with the FDA, Sesen Bio Inc., plans to conduct an additional Phase III clinical trial for Vicineum for the treatment of NMIBC (non-muscle invasive bladder cancer) in connection with the potential resubmission of a BLA.
The Company plans to request a meeting with the FDA in the coming weeks to align on the remaining outstanding items related to the additional Phase III clinical trial.
Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.
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