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
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