The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to NUV-422, a cyclin-dependent kinase (CDK) inhibitor developed by Nuvation Bio. NUV-422 was developed for the treatment of patients with high-grade gliomas, aggressive tumors that can be found in the brain, most often of men and women between 30-50. The new drug works be penetrating the blood-brain barrier and inhibiting CDK 2, 4, and 6, effectively cutting off the tumor’s escape path. These tumors are difficult to fully remove and have traditionally been targeted using approaches including chemotherapy, neurosurgery, and radiation therapy. The company, Nuvation Bio, develops therapeutic candidates to address the unmet needs in oncology and develops solutions for the most difficult-to-treat cancers.

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