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BY HEMANTH AT 9:45 AM ET-
Sesen Bio [SESN] a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration(FDA) regarding its Biologics License Application (BLA) for Vicineum™ (oportuzumab monatox-qqrs) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
The FDA has determined that it cannot approve the BLA for Vicineumin its present form and has provided recommendations specific to additional clinical/statistical data and analyses in addition to Chemistry,Manufacturing and Controls (CMC) issues pertaining to a recent pre-approval inspection and product quality.
“We are deeply disappointed by this unexpected result, and it is an unfortunate day for patients suffering from BCG-unresponsive NMIBC,” said Dr. Thomas Cannell, president, and chief executive officer of Sesen Bio. “We remain dedicated to our mission to save and improve the lives of patients by bringing new treatment options to patients, and we intend to work closely with the FDA to understand next steps.”
The Company plans to request a Type A meeting as soon as possible with the FDA to discuss the next steps that are needed before the application may be approved.