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 (FDA) for GLR2007 for the treatment of malignant glioma, an aggressive primary brain tumor.

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.”