Posted by Michael Wonder on 06 Oct 2020
Y-mAbs provides regulatory update on omburtamab for the treatment of patients with neuroblastoma
5 October 2020 - Y-mAbs Therapeutics today announced that Y-mAbs has received a Refusal to File letter from the U.S. FDA regarding the biologics license application for omburtamab for the treatment of paediatric patients with CNS/leptomeningeal metastasis from neuroblastoma, which was submitted in August 2020.
Upon preliminary review, the FDA determined that certain parts of the Chemistry, Manufacturing and Controls module and the Clinical module of the application require further detail. No additional non-clinical data have been requested or are required.
Y-mAbs is confident that it can address all points raised by the FDA, including providing the requested additional Chemistry, Manufacturing and Controls information and supplementary data from Study 101, which will include tumour response data from patients with evaluable disease among the first 24 patients included in the protocol.
