21 August 2018 - Y-mAbs Therapeutics today announced that the company has received a breakthrough therapy designation for naxitamab, 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.

Y-mAbs Founder, President and Head of Business Development and Strategy, Thomas Gad said, “We are very pleased that the FDA has granted the Breakthrough Therapy designation to naxitamab and we look forward to continuing to work with the FDA to make this therapy potentially available to children facing an unmet medical need. We believe that naxitamab provides a new opportunity for paediatric patients otherwise faced with little or no options. This is an important milestone achievement for YmAbs, and we continue to work with the regulatory authorities to advance naxitamab to patients suffering from high risk neuroblastoma as quickly as possible.”

Read YmAbs press release