BRIEF—Koselugo approved in China for pediatric patients

9 May 2023

Koselugo (selumetinib) has been approved in China for the treatment of symptomatic, inoperable plexiform neurofibromas in pediatric patients with neurofibromatosis type I (NF1) aged three years and above.

The approval by the National Medical Products Administration (NMPA) was based on positive results from the SPRINT Stratum I trial, which showed that the oral treatment option reduced the size of inoperable tumors in children.

In addition to China, Koselugo is also approved in the USA, EU, Japan and several other countries.

The therapy is subject to a global strategic collaboration targeting multiple cancer types, agreed between AstraZeneca and Merck & Co, which began in 2017.



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