Post by icemandios on Aug 25, 2021 12:40:03 GMT
Item 8.01 – Other Events.
On August 20, 2021, Sesen Bio, Inc. (the “Company”) withdrew its marketing authorization application (“MAA”) to the European Medicines Agency (“EMA”) for Vysyneum™ for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (“NMIBC”).
Given that certain components in the EMA’s review are interrelated with elements of the US Food and Drug Administration’s (“FDA”) decision to issue a complete response letter regarding the Company’s Biologics License Application (“BLA”) for Vicineum™ for the treatment of BCG-unresponsive NMIBC, 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 United States.
Sesen Bio plans to request a Type A meeting as soon as possible with the FDA to discuss next steps for the potential regulatory path forward for Vicineum in the US, and the Company expects this meeting to occur in the fourth quarter of this year.
The Company believes additional information from the FDA will equip the Company to better synchronize the regulatory reviews of Vicineum in the US and Europe. Sesen Bio is committed to the highest standards of ethics and integrity and continues to believe in the safety and efficacy data of Vicineum. The Company intends to work closely with the FDA to understand next steps.
On August 20, 2021, Sesen Bio, Inc. (the “Company”) withdrew its marketing authorization application (“MAA”) to the European Medicines Agency (“EMA”) for Vysyneum™ for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (“NMIBC”).
Given that certain components in the EMA’s review are interrelated with elements of the US Food and Drug Administration’s (“FDA”) decision to issue a complete response letter regarding the Company’s Biologics License Application (“BLA”) for Vicineum™ for the treatment of BCG-unresponsive NMIBC, 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 United States.
Sesen Bio plans to request a Type A meeting as soon as possible with the FDA to discuss next steps for the potential regulatory path forward for Vicineum in the US, and the Company expects this meeting to occur in the fourth quarter of this year.
The Company believes additional information from the FDA will equip the Company to better synchronize the regulatory reviews of Vicineum in the US and Europe. Sesen Bio is committed to the highest standards of ethics and integrity and continues to believe in the safety and efficacy data of Vicineum. The Company intends to work closely with the FDA to understand next steps.