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.”

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

Related posts

• Seattle Genetics signs $4.4bn worth oncology deals with Merck (0)
• Gilead acquisition of Immunomedics : Pharma giant to gain access to breast cancer drug Trodelvy (0)
• Reyvow CENTURION trial results : Lilly migraine drug succeeds in phase 3 study (0)
• Bruker acquires Missouri-based life science company Canopy Biosciences (0)
• United Therapeutics appoints Dr Linda Maxwell to board of directors (0)
• KA Imaging gets FDA clearance for Reveal X-ray detector (0)
• RELIEF-DPN-1 clinical trial : Lexicon begins patient dosing with LX9211 (0)
• FDA accepts Ascendis Pharma’s TransCon hGH BLA for pediatric GHD (0)
• Nestlé to fully own Aimmune Therapeutics through $2bn deal (0)
• Ionis Pharmaceuticals to take full ownership of Akcea Therapeutics (0)