(Neuroblastoma) Pediatric Cancer Update: UNITUXIN Enters Clinical Use

On September 22, 2021, UNITUXIN — Japan's first approved drug capable of suppressing relapse in refractory pediatric neuroblastoma — entered clinical use.

Approximately 160 children in Japan are diagnosed with neuroblastoma each year. The disease is difficult to treat due to repeated relapses, with about 60% of cases presenting with metastasis, and fewer than half of affected children surviving five years.

Approval of the anti-GD2 antibody UNITUXIN was based on clinical trial results conducted in 2013 by a research team at the Osaka City General Medical Center.

The trial demonstrated that 80% of patients had no relapse for at least two years after administration.

UNITUXIN was approved in the United States five years prior and has been widely used as a standard treatment. Due to the small number of pediatric patients in Japan, development of the drug had been slow to progress.

Dr. Junichi Hara, Deputy Director of the Osaka City General Medical Center, which conducted the clinical trial, stated that the approval and clinical availability of this necessary drug for children with neuroblastoma will significantly improve survival rates. Japan lacks legislation requiring pediatric drug development, but should establish systems similar to those in Europe and North America.

Source: https://www3.nhk.or.jp/news/html/20210922/k10013270901000.html

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