News >

FDA Approval Sought for Naxitamab in Neuroblastoma

Jason M. Broderick @jasoncology
Published: Saturday, Apr 04, 2020

Y-mAbs Therapeutics, Inc., has completed submission of a Biologics License Application (BLA) to the FDA for naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma.1

Commenting on the BLA submission, Claus Moller, MD, PhD, chief executive officer of Y-mAbs, said in the press release, “With this submission, we look forward to working with the [FDA] to bring naxitamab to appropriate patients. We are excited to complete this submission and believe naxitamab can address a significant unmet medical need for children with relapsed/refractory high-risk neuroblastoma.”


  1. Y-mAbs Announces Submission of Naxitamab Biologics License Application to U.S. FDA. Published April 1, 2020. Accessed April 4, 2020.
  2. Y-mAbs Announces Naxitamab Update. Published October 25, 2019. Accessed April 4, 2020.
  3. Y-mAbs Receives Breakthrough Therapy Designation for Naxitamab for the treatment of High Risk Neuroblastoma. Published August 21, 2018. Accessed April 4, 2020.

... to read the full story
To Read the Full Story

View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Publication Bottom Border
Border Publication