Which monoclonal antibody was the first immunotherapy agent approved by the FDA specifically for pediatric cancer?

Dinutuximab is recognized as the first immunotherapy agent approved by the FDA specifically for pediatric cancer, particularly for the treatment of high-risk neuroblastoma. This approval was significant as it marked a milestone in the use of monoclonal antibodies to treat childhood cancers, which have historically had fewer targeted therapies compared to adult cancers.

The mechanism of action of dinutuximab involves targeting the GD2 antigen, which is commonly found on the surface of neuroblastoma cells. By binding to this antigen, dinutuximab helps the immune system recognize and attack the cancer cells, enhancing the overall therapeutic effect. The approval of dinutuximab has provided new hope for treating a challenging pediatric malignancy and has paved the way for further developments in immunotherapy for children with cancer.

Other monoclonal antibodies mentioned have important roles in different cancers but were not the first to be approved for pediatric use specifically, which is crucial in understanding the landscape of pediatric oncology pharmacotherapy. For example, rituximab is primarily used for non-Hodgkin lymphoma and certain types of leukemia in both adults and children, while nivolumab and trastuzumab are used in adult cancers and some specific cases in pediatric settings but do not