Y-mAbs pushes back re-submission of its neuroblastoma BLA to end of 2021

 Y-mAbs Therapeutics on Wednesday again adjusted its timeline for re-submitting its neuroblastoma drug omburtamab to the FDA, saying the submission won’t likely happen until the end of 2021.

“Y-mAbs agreed to provide the agency with additional detailed data and the statistical analysis plan (‘SAP’) and anticipates being able to do so during the third quarter of 2021. Upon receiving the FDA’s feedback on these items, we expect to move forward and request a Type B pre-BLA meeting. Pending a positive Type B pre-BLA meeting, we aim to initiate rolling resubmission of the omburtamab BLA by the end of the year,” the New York-based biotech said in a statement.

But back in October, when the FDA handed Y-mAbs Therapeutics a refuse-to-file letter, citing the need for more manufacturing and clinical data on the drug, the company said that it would resubmit the omburtamab application before the end of 2020. Y-mAbs also previously said in February that it would resubmit its BLA in the second or third quarter of this year.

But beyond the shifting of the timeline, Y-mAbs CEO Claus Moller said the company and FDA are now aligned, “on the next step towards the resubmission of the omburtamab BLA, and believe that, if approved, omburtamab can be of significant benefit to children with CNS/leptomeningeal metastasis from neuroblastoma.”

Omburtamab targets B7-H3, an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types. Y-mAbs’ BLA is geared toward the treatment of pediatric patients with CNS/leptomeningeal metastases from neuroblastoma, which s a personal focus for Y-mAbs founder Thomas Gad, whose daughter was diagnosed with high-risk neuroblastoma at age 2, according to the company’s S-1. Initially, the BLA submission was based on the safety and efficacy results of two Phase II studies and began last June.

The FDA in November also gave the biotech an accelerated OK for its other neuroblastoma drug, naxitamab, as a second-line treatment in combination with granulocyte-macrophage colony-stimulating factor — but with a box warning. The ex-Genmab execs running Y-mAbs snagged both naxitamab and omburtamab from Memorial Sloan Kettering.

https://endpts.com/y-mabs-pushes-back-re-submission-of-its-neuroblastoma-bla-to-end-of-2021/