Y-mabs gets FDA breakthrough therapy designation for neuroblastoma candidate burtomab

Y-mabs Therapeutics Inc. (New York, N.Y.) said FDA granted breakthrough therapy designation to burtomab (I-8H9) to treat pediatric patients with relapsed or refractory neuroblastoma with CNS or leptomeningeal metastasis.

The company has reported data from a pivotal trial in 80 pediatric patients with neuroblastoma-associated CNS and leptomeningeal metastasis wherein burtomab led to an average survival of 58 months vs. 4.7 months for a contemporary cohort in the Central German Childhood Cancer Registry. According to Y-mabs, there are no approved therapies for the indication...