Published On: Tue, Apr 6th, 2021

Gan & Lee gets EMA orphan drug status for GLR2007 in glioma

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Gan & Lee Pharmaceuticals has been granted orphan drug designation for from the European Medicine Agency (EMA) for the 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).

Gan & Lee gets EMA orphan drug status for GLR2007 in glioma

Gan & Lee gets EMA orphan drug status for GLR2007 in glioma. Photo courtesy of NakNakNak from Pixabay.

Dr. – 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 having glioblastoma, a fast-growing glioma.

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