On December 1, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that the U.S. Food and Drug Administration ("FDA") has issued a complete response letter ("CRL") for the Biologics License Application ("BLA") for the investigational medicine 131I-omburtamab ("omburtamab") for the treatment of CNS/leptomeningeal metastasis from neuroblastoma (Press release, Y-mAbs Therapeutics, DEC 1, 2022, View Source [SID1234624723]).
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The letter indicates that the FDA completed the review of the application and determined that it is unable to approve the BLA in its current form. This is consistent with the outcome of the Oncologic Drugs Advisory Committee Meeting in October. The CRL includes a recommendation for meeting with the agency to discuss adequate and well-controlled trial design to demonstrate substantial evidence of effectiveness and a favorable benefit-risk profile.
Y-mAbs is assessing the implications of the CRL and its plans for the omburtamab program.
"We are disappointed by the CRL but not surprised based on the outcome of the ODAC meeting on October 28. We want to express our gratitude to all the patients, their families, and investigators who have participated in our clinical trials and advocated for the advancement of omburtamab," said Thomas Gad, President, and Interim Chief Executive Officer. "While we evaluate the implications of the CRL for the future of omburtamab, we are excited about refining our focus primarily to drive growth from DANYELZA and validate our SADA platform in the clinic, with the goal of bringing innovative solutions to patients and value to our shareholders.
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.