Sesen Bio Receives Complete Response Letter from FDA for Vicineum™ (oportuzumab monatox-qqrs)
Company to host conference call on Monday, August 16 at 8:00 a.m. ET
Sesen Bio (NASDAQ: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 Vicineum in its present form and has provided recommendations specific to additional clinical/statistical data and analyses in addition
