FDA Grants Fast Track Designation for New Breast Cancer Treatment

The U.S. Food and Drug Administration (FDA) has released a new fast track designation for IDE161, an inhibitor of poly (ADP-ribose) glycohydrolase (PARG) to treat adult patients with advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor 2 receptor (HER2)-negative breast cancer.

Patients within this population have germline or somatic BRCA ½ mutations that have progressed following treatment with at least one line of hormonal therapy, an inhibitor (CDK4/6) therapy and a poly polymerase (targets proteins)(PARP) inhibitor therapy, according to a press release from BioSpace.

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