IDEAYA Biosciences: IDE161 Granted Fast Track Status By FDA

(RTTNews) - IDEAYA Biosciences, Inc. (IDYA) said the FDA has granted Fast Track designation to development program investigating IDE161 for the treatment of adult patients having advanced or metastatic hormone receptor positive, 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 polymerase inhibitor therapy. The company noted that this represents a second indication in the IDE161 development program to receive Fast Track designation, complementing the designation for BRCA1/2 mutant ovarian cancer patients.

The company is targeting program updates for IDE161 in the fourth quarter of 2023. IDEAYA owns or controls all commercial rights in IDE161 under worldwide license with Cancer Research UK and University of Manchester.

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