STAT+: Sesen Bio pulls E.U. application for FDA-rejected cancer drug

Sesen Bio, a small biotech firm whose investigational cancer treatment once seemed poised for approval, said Wednesday that it had withdrawn its application to market the drug in Europe.

The news follows the Food and Drug Administration’s decision to reject Sesen’s drug, called Vicineum, on Aug. 13. Last week, STAT reported that Sesen’s clinical trial in bladder cancer was marked by thousands of violations, investigator misconduct, and evidence of serious toxicity the company did not publicly disclose, according to hundreds of pages of internal documents.

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