Monday, October 31, 2022
Y-mAbs Therapeutics, Inc., a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced the outcome of the meeting of the U.S. Food and Drug Administration (“FDA”) Oncologic Drugs Advisory Committee (“ODAC”), which reviewed investigational 131I-omburtamab (“omburtamab”) for the treatment of CNS/leptomeningeal metastasis from neuroblastoma. The committee voted 16 to 0 that the Company had not provided sufficient evidence to conclude that omburtamab improves overall survival.
“We are disappointed by the outcome of today’s meeting, as patients with CNS/leptomeningeal metastasis from neuroblastoma are in need of effective and safe treatment options,” said Thomas Gad, President, and Interim Chief Executive Officer. “Y-mAbs is committed to working closely with the FDA on their review of the Biologic License Application (“BLA”) for omburtamab ahead of their decision. We want to thank all of the patients, caregivers, and healthcare providers who participated in the studies of this life-threatening condition.”
ODAC reviewed data from omburtamab’s clinical development program with a focus on study 03-133 (a pivotal phase 1 study) and study 101 (a pivotal phase 2 study) as well as the historical control group.
Y-mAbs BLA submission for omburtamab was accepted for Priority Review by the FDA on May 31, 2022, with a Prescription Drug User Fee Act (“PDUFA”) target date of November 30, 2022. The FDA is not bound by the Advisory Committee’s recommendations but generally takes the recommendation into consideration when making its decision.
Researchers at MSK developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound.