Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, have announced that a meeting of the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) has been scheduled for October 28, 2022 to review the Company’s Biological License Application (BLA) for its product candidate, OMBLASTYS (omburtamab), an investigational radiolabeled antibody construct.
Y-mAbs resubmitted the BLA for OMBLASTYS on March 31, 2022, and the FDA assigned a Prescription Drug User Fee Act goal date of November 30, 2022, for the completion of its priority review of the OMBLASTYS BLA.
