FDA grants accelerated approval to Danyelza

The US Food and Drug Administration has granted accelerated approval for Danyelza (naxitamab) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for pediatric patients one year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow demonstrating a partial response, minor response, or stable disease to prior therapy.

The drug was developed by Y-mAbs Therapeutics (Nasdaq: YMAB), a Denmark-founded biotech formed in 2015 by former senior managers at Genmab (OMX: GEN), with headquarters in New York.

Danyelza is expected to be available in the USA in the coming weeks, said the company, whose shares gained more than 10% in after-hours trading on Wednesday.