Published On: Sat, Aug 14th, 2021

FDA Declines to Approve Sesen Bio’s Bladder Cancer Treatment, Shares Plunge

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The Food and Drug Administration (FDA) has declined to approve Sesen Bio Inc’s lead therapy candidate for a type of bladder cancer, the company said on Friday, sending its shares down more than 80 percent. The FDA notified the drug developer that it cannot approve the marketing application for the drug, Vicineum, in its present form. The agency has provided recommendations specific to additional clinical data and analyses in addition to issues pertaining to a recent pre-approval inspection and product quality, the company added. Sesen Bio said it plans to request a meeting with the FDA to discuss the next steps in the regulatory pathway for the drug’s approval. Vicineum, administered via an injection, is a targeted fusion protein that targets and binds to epithelial cell adhesion molecule, a type of antigen found on the surface of tumor cells. The therapy is being developed for immunotherapy unresponsive non-muscle invasive bladder …

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