IDEAYA Biosciences has achieved Fast Track Designation from the US Food and Drug Administration (FDA) for IDE161, a breast cancer therapy that serves as a potent and selective inhibitor of poly (ADP-ribose) glycohydrolase (PARG). This designation applies to the treatment of adult patients with advanced or metastatic hormone receptor-positive (HR+), Her2- breast cancer who possess germline or somatic BRCA 1/2 mutations.
The therapy is intended for individuals who have undergone prior treatments involving at least one round of hormonal therapy, CDK4/6 inhibitor therapy, and poly (ADP-ribose) polymerase (PARP) inhibitor therapy.
IDE161’s Fast Track Designation represents a significant milestone in the IDE161 development program. IDEAYA Biosciences is currently conducting a Phase I clinical study, the first-in-human study, to evaluate the therapy’s safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in patients with solid tumors exhibiting homologous recombination deficiency (HRD).
Previous clinical data from dose escalation cohorts have indicated preliminary tumor shrinkage in several patients with HRD and individuals with BRCA 1/2-mutant endometrial and colon cancers.
The Phase I trial’s expansion phase will encompass patients with HRD+ breast cancer, ovarian cancer, and other selected solid tumors.
Dr. Darrin Beaupre, Chief Medical Officer of IDEAYA Biosciences, emphasized that the FDA’s Fast Track Designations for IDE161 underscore the therapy’s potential to address the substantial unmet medical needs in both BRCA1/2-mutant breast and ovarian cancers.
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