Pharma Focus Asia

Phase 1 Drug Candidate GLR2007, Developed by Gan & Lee, Received Fast Track Designation from the US FDA

Monday, February 01, 2021

Gan & Lee Pharmaceuticals Co., an international biopharmaceutical company,announced that the Food and Drug Administration (FDA ) has granted GLR2007 Fast Track designation for the treatment of patients with glioblastoma. GLR2007 is a cyclin-dependent 4/6 kinase inhibitor (CDK 4/6) that Gan & Lee is developing for the treatment of advanced solid tumors, including glioblastoma, an aggressive form of brain cancer with low levels of survival. Although considered a rare disease, glioblastoma is the most common malignant tumor of the brain and central nervous system (CNS), accounting for 45,

The one-year survival rate for glioblastoma is 39.3%. It drops to 16.9% and 5.5%, respectively in the second year and the fifth year after diagnosis. The average survival time of untreated patients is only three months [2] . The treatments currently available only improve the prognosis by a few months. According to Julius Huang, Director of Global Clinical Sciences at Gan & Lee, “The poor prognosis and poor survival rates for glioblastomas demonstrate an unmet need for new treatment options. The FDA's Fast Track designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and to meet an unmet medical need. Obtaining the Fast Track designation enhances frequent meetings and written communication with the FDA. The GLR2007 application is also eligible for continuous review and may be eligible for expedited approval and priority review

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