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Association details:
| Biomarker: | HR positive + BRCA1 mutation |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | IDE161 (PARG inhibitor) |
| Direction: | Sensitive |
Evidence:
Title:
IDEAYA Biosciences Receives Fast Track Designation for IDE161 in a Second Indication for the Treatment of Pretreated, Advanced or Metastatic HR+, Her2-, BRCA1/2 mutant Breast Cancer
Published date:
09/27/2023
Excerpt:
IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to IDEAYA's development program investigating IDE161, a potent and selective inhibitor of poly (ADP-ribose) glycohydrolase (PARG), for the treatment of adult patients having advanced or metastatic hormone receptor positive (HR+), Her2- breast cancer with germline or somatic BRCA 1/2 mutations who have progressed following treatment with at least one line of a hormonal therapy, a CDK4/6 inhibitor therapy and a poly (ADP-ribose) polymerase (PARP) inhibitor therapy.
