Sesen Bio now pulls Vysyneum regulatory filing in Europe

27 August 2021

USA-based oncology specialist Sesen Bio (Nasdaq: SESN), in a filing with the US Securities and Exchange Commission (SEC), revealed that it has withdrawn its marketing authorization application (MAA) to the European Medicines Agency for Vysyneum (oportuzumab monatox) for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC).

The announcement comes shortly after it received news that the US Food and Drug Administration had issued a Complete Response Letter (CRL) for Vicineum (oportuzumab monatox-qqrs) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer

Given that certain components in the EMA’s review are interrelated with elements of the US FDA’s decision to issue a CRL, the company is pausing its plans to pursue regulatory approval of Vysyneum in Europe until there is more clarity from the FDA on the next steps in the USA.

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