Y-mAbs Announces Initiation of Submission of Omburtamab Rolling Biologics License Application to the FDA
The non-clinical portion and a part of the CMC portion of the rolling BLA were submitted during
“As the father of a long-term high-risk neuroblastoma survivor with CNS/Leptomeningel metastasis, I know how important this potentially is for families faced with brain metastasis from high-risk neuroblastoma and I am excited to see the initiation of Y-mAbs’ second BLA submission this year in neuroblastoma. We believe this is a key milestone for families facing CNS/leptomeningeal metastases from neuroblastoma and for Y-mAbs. We are very grateful to all clinical sites involved in developing omburtamab, and especially to our employees in the development team.” stated
Dr.
Researchers at
About Y-mAbs
Y-mAbs is a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. The Company has a broad and advanced product pipeline, including two pivotal-stage product candidates—naxitamab and omburtamab—which target tumors that express GD2 and B7-H3, respectively.
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Source: Y-mAbs Therapeutics, Inc