Burtomab, a drug for metastatic neuroblastoma, created by Memorial Sloan Kettering Cancer Center (MSK), 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. Nai-Kong Cheung, MD, PhD, a medical oncologist at MSK, who has spent decades conducting pioneering research in developing treatments for neuroblastoma, 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.