NEW YORK, June 7, 2017 – Burtomab, a drug for metastatic neuroblastoma, created by Memorial Sloan Kettering Cancer Center (MSK) and licensed to Y-mAbs Therapeutics, Inc. (YmAbs), has been granted Breakthrough Therapy Designation by the FDA for the treatment of pediatric patients with relapsed or refractory neuroblastoma with central nervous system or leptomeningeal metastasis. MSK’s Nai-Kong Cheung, MD, PhD, created and tested the antibody that resulted in the breakthrough therapy designation.
Breakthrough Therapy Designation is a program intended to expedite the development and review of drugs to treat serious or life-threatening diseases in cases where preliminary clinical evidence shows that the drug may provide substantial improvements over available therapy. The Breakthrough Therapy Designation for burtomab was granted on the basis of data from a pivotal clinical study of burtomab with radiolabeled iodine (131I) for the treatment of neuroblastoma that metastasize to the central nervous system or the leptomeninges.
Bertomab (8H9) is an antibody used to treat CNS NB relapses, it is one of the only options available to kids with a CNS relapse and is only available at Memorial Sloan Kettering.
I hope this means that we are one step closer to having this drug available in more locations.