Y-mAbs Announces Completion of Pre-BLA Meeting with FDA for Omburtamab
A data readout from a single-center clinical study (Study 03-133) of omburtamab conducted at Memorial
“We are pleased with the outcome of the pre-BLA meeting for omburtamab providing a clear regulatory path forward for the resubmission of the BLA. We believe omburtamab has the potential to make a meaningful impact in addressing a substantial unmet medical need for children suffering from high-risk neuroblastoma brain tumors and may potentially add an important treatment option to doctors and families facing this diagnosis,” said
Researchers at MSK developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of the licensing arrangement, MSK has institutional financial interest related to the compound.
Y-mAbs is a commercial-stage 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 one FDA approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one pivotal-stage product candidate, omburtamab, which targets tumors that express B7-H3.
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Source: Y-mAbs Therapeutics, Inc