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Sesen Bio Announces Successful Application Orientation Meeting With FDA For Vicineum


Benzinga | Feb 1, 2021 08:03AM EST

Sesen Bio Announces Successful Application Orientation Meeting With FDA For Vicineum

Sesen Bio (NASDAQ:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today reported that on January 29, 2021 the Company participated in a productive Application Orientation Meeting with the FDA regarding its Biologic License Application (BLA) for Vicineum, for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

After the Company submitted its BLA to the FDA in December 2020, Sesen Bio was invited to participate in an Application Orientation Meeting, which is available in certain Center for Drug Evaluation and Research (CDER) review divisions, at the review team's discretion, for priority applications where early action is expected and/or desired. The objectives of an Application Orientation Meeting include familiarizing the FDA with application datasets, discussing scientific aspects including clinical risk-benefit, and establishing early communication between applicants and the FDA.

"We are very pleased with the outcome of Friday's 90-minute meeting with the FDA," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "We continue to believe Vicineum has a favorable risk-benefit profile which positions it to be best-in-class, and we are encouraged by the high level of time and engagement the FDA has demonstrated toward our review. We look forward to continuing to work with the FDA to expeditiously bring Vicineum to the market."

The Company expects to learn if the BLA is accepted for filing by the FDA on February 16, 2021. If the file is accepted, in the following two to four weeks, the Company expects to receive a decision on the following three items:

* Priority vs. Standard review

* Target PDUFA date for approval

* Necessity of an FDA Advisory Committee meeting







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