Y-mAbs Therapeutics, a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, announced that it has submitted to the U.S. Food and Drug Administration (“FDA”) the first portions of its Biologics License Application (“BLA”) for naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma under the FDA’s Rolling Review process.
“We are excited to announce the initiation of the rolling BLA for naxitamab, a major milestone for Y-mAbs. Dr. Nai-Kong Cheung and his research team at Memorial Sloan Kettering Cancer Center (“MSK”) started looking at immunotherapy more than three decades ago when he first studied the anti-GD2 target. Today, high-risk neuroblastoma patients are being treated with naxitamab worldwide in clinical trials addressing clear unmet medical needs of children waiting for new treatment options,” said Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.