FDA Grants Fast Track to PC14586, Potential Therapy for Specific p53 Mutation

FDA Grants Fast Track to PC14586, Potential Therapy for Specific p53 Mutation
The U.S. Food and Drug Administration (FDA) has granted fast track status to PC14586, PMV Pharmaceuticals’ lead therapeutic candidate for the treatment of patients with locally advanced or metastatic solid tumors, including breast cancer, who have a specific mutation in the gene that encodes the tumor suppressor protein p53. A fast track designation facilitates the development of potential treatments that cater to unmet medical needs in serious conditions. Medication candidates receiving such status may be eligible for certain benefits, including more frequent interactions with the FDA, and may qualify for priority review, which can speed regulatory approvals. Currently, there are no FDA-approved treatments that target this specific mutation, called Y220C, in the p53 protein gene. This designation also is expected to support the launch of an upcoming Phase 1/2 clinical trial, called PMV-586-101 (NCT04585750), which will investigate the safety, tolerability, pharmacological properties, and anti-tumor activity of PC14586 in adults with advanced solid tumors carrying the p53 Y220C mutation. The study, which is not yet recruiting participants, is expected to start later thi
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