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a small biotech firm whose investigational cancer treatment once seemed poised for approval, said Wednesday that it had withdrawn its application to market the drug in Europe.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.
Sesen pulled its European application on Aug. 20 but did not disclose it until five days later in a filing with the Securities and Exchange Commission. The company did not issue a press release. In its filing, Sesen said that because “certain components” of the European Medicines Agency’s review are “interrelated” with the FDA’s decision to reject Vicineum, the company is pausing its plans to seek European approval “until there is more clarity from the FDA on the next steps in the United States.”
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