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Sesen, still reeling from FDA rejection, pulls filing for EU approval of cancer drug

August 26, 2021


The rapid unraveling of Sesen Bio goes on. Two weeks ago, the biotech was on the cusp of winning FDA approval for cancer drug Vicineum and working its way toward authorization in Europe. Now, with the FDA rejecting Vicineum days before a media report of misconduct, Sesen has pulled its filing to the European Medicines Agency (EMA).

Massachusetts-based Sesen withdrew its EMA submission Aug. 20, a week after the FDA rejection and two days after the Stat report of misconduct, but only disclosed the action in a regulatory filing on Wednesday. The filing is light on details.

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