IDEAYA Biosciences Gets FDA Fast-Track Designation for IDE161 in Ovarian Cancer

By Colin Kellaher

IDEAYA Biosciences has won U.S. Food and Drug Administration fast-track designation for its IDE161 program in certain patients with ovarian cancer.

The South San Francisco, Calif., precision-medicine oncology company on Tuesday said the designation covers IDE161 for the treatment of adults having advanced or metastatic ovarian cancer with germline or somatic BRCA 1/2 mutations who are platinum resistant and have received prior antiangiogenic and poly polymerase inhibitor therapies.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

IDEAYA is conducting a Phase 1 first-in-human study evaluating the safety, tolerability, pharmacokinetic and pharmacodynamic properties and preliminary efficacy of IDE161 in patients having solid tumors with homologous recombination deficiency.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

September 26, 2023 06:27 ET (10:27 GMT)

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