Y-Mabs Initiates Rolling BLA Submission of Breakthrough Drug Naxitamab for Neuroblastoma

Y-Mabs Initiates Rolling BLA Submission of Breakthrough Drug Naxitamab for Neuroblastoma

Y-Mabs announced it has submitted the first portions of its Biologics License Application (BLA) to the U.S. FDA requesting approval for naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma under the FDA’s Rolling Review process. The Rolling Review process allows Y-mAbs to submit individual portions of the BLA for review, rather than waiting until all portions are completed and submitted to the FDA for review. 

Naxitamab received Breakthrough Therapy Designation by the FDA in August of 2018 for use in combination with GM-CSF, for the treatment of high risk neuroblastoma refractory to initial therapy or with incomplete response to salvage therapy in patients older than 12 months of age with persistent, refractory disease limited to bone marrow with or without evidence of concurrent bone involvement. 

A clinical update on naxitamab for the treatment of neuroblastoma and osteosarcoma, was made at the International Society of Pediatric Oncology (SIOP) Annual Congress held in Lyon, France in October of 2019.

About naxitamab

Naxitamab is a monoclonal antibody (mAb) that binds the tumor target GD2, which is abundantly found on neuroblastoma ...

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