Benzinga | Oct 19, 2021 04:11PM EDT

Sesen Bio 8-K Shows FDA Granted Co. Request For Type A Meeting To Discuss Issues Raised In FDA's Complete Response Letter Related To Vicineum

On the morning of October 19, 2021, the US Food & Drug Administration ("FDA") granted Sesen Bio, Inc.'s (the "Company") request for a Type A meeting to discuss the Chemistry, Manufacturing and Controls ("CMC") issues raised in the FDA's Complete Response Letter ("CRL") regarding the Company's Biologics License Application ("BLA") for Vicineum(tm) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (the "CMC Type A Meeting"). The CMC Type A Meeting has been scheduled for October 29, 2021.



During the CMC Type A Meeting, the Company intends to align on a path forward with the FDA related to the CMC issues raised in the CRL.



The Company is also preparing for a separate Type A meeting to discuss the recommendations specific to additional clinical/statistical data and analyses that the FDA raised in the CRL (the "Clinical Type A Meeting"). The Company expects the Clinical Type A Meeting to occur later in the fourth quarter of 2021.



As previously disclosed, the Company intends to use the information from the CMC Type A Meeting and the Clinical Type A Meeting to synchronize the regulatory reviews of Vicineum for the treatment of BCG-unresponsive NMIBC in the US and the European Union. The Company looks forward to continuing to work collaboratively with regulators to determine the appropriate path forward.