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 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.

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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. 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.”

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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.

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