Y-mAbs Reports Initiation of Rolling Review of BLA for Naxitamab to the US FDA to Treat Neuroblastoma

Y-mAbs Reports Initiation of Rolling Review of BLA for Naxitamab to the US FDA to Treat Neuroblastoma

Shots:

  • In Aug, 2018 naxitamab received the US FDA’s Breakthrough Therapy Designation for the treatment of high-risk neuroblastoma
  • The rolling review process of the US FDA provides 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 is an anti-GD2 mAb and has received Orphan Drug Status from the US FDA in both neuroblastoma and osteosarcoma, and is currently in a P-II clinical trial for MSK

Click here to­ read full press release/ article | Ref: GlobeNewswire | Image: Behance