Published On: Sat, Sep 12th, 2020

Gan & Lee gets FDA orphan drug status for GLR2007 in malignant glioma

Gan & Lee Pharmaceuticals has been given orphan drug designation from the US Food and Drug Administration () for GLR2007 for the treatment of malignant glioma, an aggressive primary brain .

According to the Chinese biopharma company, GLR2007 is an inhibitor of cyclin-dependent kinase 4/6 (CDK 4/6), which is being developed for the treatment of advanced solid tumors.

Michelle Mazuranic – Gan & Lee Pharmaceuticals EU/US Head of Medical Affairs said: “There is significant unmet medical need in this patient population, and this orphan drug designation represents an important milestone in the Gan & Lee clinical development program investigating GLR2007.”

Presently, the Chinese biopharma company is enrolling patients for a phase 1 clinical trial of GLR2007 to determine the safety, tolerability, and optimal dosing strategy in patients having advanced solid tumors.

Kai Du – CEO of Gan & Lee Pharmaceuticals said: “Receiving Orphan Drug Designation for GLR2007 is a positive step forward in the development of this clinical program.”

Gan & Lee gets FDA orphan drug status for GLR2007 in malignant glioma

Gan & Lee gets FDA orphan drug status for GLR2007 in malignant glioma. Image courtesy of Raman Oza from Pixabay.

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