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▎Y-mAbs Therapeutics, editor of WuXi AppTec's content team, recently announced that the company has completed the submission of the Biologics License Application (BLA) for the radioimmunotherapy I131-omburtamab to the US FDA
.
Omburtamab is an investigational monoclonal antibody targeting B7-H3, an immune checkpoint molecule widely expressed in tumor cells of several cancer types
.
Omburtamab's BLA is indicated for the treatment of pediatric patients with neuroblastoma with CNS/leptomeningeal metastases
.
By combining radioactive iodine (I131) with an antibody targeting B7-H3, it is possible to kill cancer cells while reducing toxicity to healthy cells
.
This submission is based on safety and efficacy results from a pivotal Phase 2 clinical trial
.
Results published on the Y-mAbs official website showed that among the 10 treated children, the disease control rate reached 90% after 26 weeks of treatment, including two patients with partial and two complete responses
.
Image source: Y-mAbs official website Y-mAbs CEO Dr.
Claus Moller said: "We believe this radioimmunotherapy could potentially address the significant unmet need in children with neuroblastoma with CNS/pial metastases
.
We Looking forward to working with the US FDA to bring it to the right patients
.
"Reference: [1] Y-mAbs Announces Submission of Omburtamab Biologics License Application to FDA.
Retrieved April 1, 2022, from https:// /en/Y-mAbs-Announces-Submission-of-Omburtamab-Biologics-License-Application-to-FDA.
htmlDisclaimer: The WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only , the opinions in this article do not represent the position of WuXi AppTec, nor do they support or oppose the opinions expressed in the article
.
This article is not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital for treatment
.
.
Omburtamab is an investigational monoclonal antibody targeting B7-H3, an immune checkpoint molecule widely expressed in tumor cells of several cancer types
.
Omburtamab's BLA is indicated for the treatment of pediatric patients with neuroblastoma with CNS/leptomeningeal metastases
.
By combining radioactive iodine (I131) with an antibody targeting B7-H3, it is possible to kill cancer cells while reducing toxicity to healthy cells
.
This submission is based on safety and efficacy results from a pivotal Phase 2 clinical trial
.
Results published on the Y-mAbs official website showed that among the 10 treated children, the disease control rate reached 90% after 26 weeks of treatment, including two patients with partial and two complete responses
.
Image source: Y-mAbs official website Y-mAbs CEO Dr.
Claus Moller said: "We believe this radioimmunotherapy could potentially address the significant unmet need in children with neuroblastoma with CNS/pial metastases
.
We Looking forward to working with the US FDA to bring it to the right patients
.
"Reference: [1] Y-mAbs Announces Submission of Omburtamab Biologics License Application to FDA.
Retrieved April 1, 2022, from https:// /en/Y-mAbs-Announces-Submission-of-Omburtamab-Biologics-License-Application-to-FDA.
htmlDisclaimer: The WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only , the opinions in this article do not represent the position of WuXi AppTec, nor do they support or oppose the opinions expressed in the article
.
This article is not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital for treatment
.
