US biopharma company Y-mAbs Therapeutics has submitted the first portions of its biologics license application (BLA) for naxitamab to the US Food and Drug Administration (FDA), seeking the drug’s approval for the treatment of relapsed/refractory high-risk neuroblastoma under the latter’s Rolling Review process.
Naxitamab, an anti-GD2 monoclonal antibody, was granted the FDA breakthrough therapy designation in August 2018, which allows frequent interactions with the regulator’s review team.
The Rolling Review process permits Y-mAbs Therapeutics to submit individual portions of the BLA for review, instead of waiting for all portions to be completed and submitted to the US drug regulator for review. Following potential approval, Y-mAbs Therapeutics plans to commercialize naxitamab in the US.
Thomas Gad – Founder, Chairman, President and Head of Business Development and Strategy at Y-mAbs Therapeutics said: “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.”
MSK has institutional financial interests with Y-mAbs Therapeutics through equity and intellectual property interests via licensing agreements.
Dr. Claus Moller – CEO of Y-mAbs Therapeutics said: “I am both proud and appreciative of the Y-mAbs team and our clinical investigators, who have helped to make this key milestone possible. We believe that this submission represents an important landmark for Y-mAbs and for neuroblastoma patients.”