Neurofibromatosis type 1 is characterized by soft lumps on and under the skin and skin pigmentation.
The approval was granted by the European Commission for children aged three and above and was based on positive results from the SPRINT Stratum 1 Phase 2 trial.
The trial, sponsored by the National Cancer Institute's Cancer Therapy Evaluation Program, showed an overall response rate of 66% in pediatric patients and reduced the size of inoperable tumors in children, reducing pain and improving quality of life.
Koselugo has already been approved in the U.S. to treat neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas on patients aged two years and older.
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