Gan & Lee gets EMA orphan drug status for GLR2007 in glioma
Gan & Lee Pharmaceuticals has been granted orphan drug designation for GLR2007 from the European Medicine Agency (EMA) for the treatment of glioma, a type of tumor found in the brain and spinal cord.
The Chinese biopharma company is currently studying GLR2007 in a phase 1 clinical trial for the treatment of advanced solid tumors.
GLR2007 is an inhibitor of cyclin-dependent kinase 4/6 (CDK 4/6).
Dr. Michelle Mazuranic – Head of Global Medical Affairs at Gan & Lee Pharmaceuticals said: “The EMA’s positive decision for GLR2007’s orphan drug designation is another milestone in the clinical development program as this compound was also recently granted ODD by the FDA.”
Earlier this year, GLR2007 was granted fast track designation from the US Food and Drug Administration (FDA) for the treatment of patients having glioblastoma, a fast-growing glioma.