Danyelz was approved by the U.S. Food and Drug Administration (FDA) on November 25, for the treatment of with relapsed/refractory high-risk neuroblastoma. Y-mAbs plans to resubmit an amended biologics license application for omburtamab for the treatment of pediatric patients with central nervous system/leptomeningeal metastasis from neuroblastoma to the FDA by the end of 2020 or early in 2021. Omburtamab targets tumors that express B7-H3.
Under the agreement, Takeda will be responsible for the sales, access, marketing, and regulatory activities to distribute Danyelza and omburtamab in the territory (State of Israel, West Bank, and Gaza Strip). All other geographies worldwide remain with Y-mAbs.
Financial details of the agreement were not disclosed.
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