The Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) has been scheduled for October 28, 2022 to review Y-mAbs Therapeutics’ YMAB Biological License Application (BLA) for its product candidate, OMBLASTYS (omburtamab) for pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma.
The company resubmitted the Biologics application in the month of March 2022.
The regulatory agency has accepted the BLA under priority review and assigned Prescription Drug User Fee Act (PDUFA) goal date of November 30, 2022.
Thomas Gad, President, and Interim Chief Executive Officer, commented: "We look forward to the October 28, 2022 meeting with the Advisory Committee, as well as to continuing our dialogue with the FDA about OMBLASTYS and the important data, which we believe supports approval. This is another key step towards providing a potential treatment for pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma."
Omburtamab was developed by researchers at Memorial Sloan Kettering Cancer Center (MSK) and licensed to Y-mAbs.
Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic cancer products.
Price Action : Y-mAbs shares closed Thursday’s trading down at $16.01
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