Y-mAbs Provides Regulatory Update on Omburtamab for the Treatment of Patients with Neuroblastoma CNS/LM Metastasis
Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) has announced its request for a pre-BLA meeting with the FDA regarding omburtamab for treating pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. The meeting is expected in January 2022, aiming for resubmission of the BLA shortly after. If successful, the FDA approval could occur by Q4 2022. The company, which has DANYELZA® approved, emphasizes the significant unmet medical need for the targeted treatment. The announcement follows a Type B meeting with the FDA.
- Request for pre-BLA meeting with FDA indicates progress for omburtamab.
- Potential FDA approval for omburtamab could be in Q4 2022.
- None.
NEW YORK, Nov. 04, 2021 (GLOBE NEWSWIRE) -- 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, today announced that, based on feedback from the U.S. Food and Drug Administration (“FDA”) at a recent Type B meeting, where the Company provided the FDA with additional detailed data and the statistical analysis plan, the Company has requested a pre-BLA meeting for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. The Company believes the pre-BLA meeting will be held in January 2022, and pending a positive meeting, the Company aims to initiate resubmission of the omburtamab BLA shortly thereafter.
“We are very pleased to be aligned with the FDA on the next step towards the resubmission of the omburtamab BLA, and believe that, if approved, omburtamab will be of significant benefit to children with CNS/leptomeningeal metastasis from neuroblastoma, who are currently facing a significant unmet medical need,” stated Thomas Gad, founder, Chairman and President.
Dr. Claus Moller, Chief Executive Officer, continued, “We are reconfirming our anticipated timeline for resubmission of the omburtamab BLA, as we believe we are still positioned to complete the submission during the course of the first quarter 2022, potentially allowing for FDA approval of omburtamab in the fourth quarter 2022.”
Researchers at Memorial Sloan Kettering Cancer Center (“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.
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. The Company has a broad and advanced product pipeline, including one FDA approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one pivotal-stage product candidate, omburtamab, which targets tumors that express B7-H3.
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DANYELZA and “Y-mAbs” are registered trademarks of Y-mAbs Therapeutics, Inc.
Contact:
Y-mAbs Therapeutics, Inc.
230 Park Avenue, Suite 3350
New York, NY 10169
USA
+1 646 885 8505
E-mail: info@ymabs.com
FAQ
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