A rolling Biologics License Application has been initiated for omburtamab for the treatment of pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma
A rolling Biologics License Application (BLA) has been initiated for omburtamab for the treatment of pediatric patients with central nervous system (CNS)/leptomeningeal metastases from neuroblastoma, according to a press release.1
Omburtamab is an investigational monoclonal antibody targeting B7-H3, which is an immune checkpoint molecule commonly expressed in the tumor cells of several cancer types. A portion of the rolling BLA has been submitted to the FDA in June 2020, and the BLA is expected to be completed over the next 4 to 6 weeks.
The BLA is based on findings from the pivotal phase 2 trials, Study 101 and Study 03-133. The safety and efficacy data from these clinical trials are expected to be presented later this year.
The company previously shared a readout on the data from the Study 03-133 trial, which evaluated 107 evaluable patients with CNS/leptomeningeal metastases from neuroblastoma; these patients received up to 2 doses of omburtamab, which led to a median survival of 50.8 months. The final median survival had not yet been reached.2
In February 2020, the company stated that they and the FDA had completed a positive Type B Pre-BLA meeting and determined an Accelerated Approval Pathway for omburtamab.
Omburtamab was developed by researchers at Memorial Sloan Kettering Cancer Center.
"We look forward to working with the Agency to bring omburtamab to appropriate patients,” said Claus Moller, chief executive officer, Y-mAbs Therapeutics, in a press release.1 “We believe omburtamab can potentially address a significant unmet medical need for children with CNS/leptomeningeal metastases from neuroblastoma."
Y-mAbs announces initiation of submission of omburtamab rolling biologics license application to the FDA. News Release. June 30, 2020. Accessed June 30, 2020. https://bit.ly/2YLCH2q
Y-mAbs announces positive pre-BLA meeting with FDA for omburtamab. News Release. February 26, 2020. Accessed June 30, 2020. https://bit.ly/3g5Rviq