IDEAYA Biosciences, Inc. (IDYA), a precision medicine oncology company, announced Tuesday that the U.S. Food and Drug Administration has granted Fast Track designation to its potential first-in-Class PARG Inhibitor, IDE161.
The designation is to treat pretreated, platinum-resistant advanced or metastatic ovarian cancer patients having tumors with BRCA1/2 mutations.
IDE161 is a potent and selective inhibitor of poly (ADP-ribose) glycohydrolase or PARG.
The U.S. FDA Fast Track designation for IDE161 is based on the FDA’s review of preclinical and emerging clinical efficacy and tolerability data.
Fast Track is a U.S. FDA process designed to facilitate the development and expedite the review of drugs to treat serious conditions.
Under the Fast Track designation, the IDE161 development program in BRCA1/2m ovarian cancer is eligible for various expedited regulatory review processes. These include generally more frequent FDA interactions, potential eligibility for rolling review of a New Drug Application or NDA and potential accelerated approval and priority review of an NDA.
Darrin Beaupre, Chief Medical Officer at IDEAYA Biosciences, said, “We recently reported preliminary clinical proof-of-concept with expansion into priority HRD+ solid tumor indications in our Phase 1 clinical trial. The Fast Track designation has been provided for platinum-resistant BRCA1/2 mutant advanced or metastatic ovarian cancer, which represents a serious condition, and acknowledges the potential for IDE161 to treat this indication.”
IDEAYA’s Phase 1 first-in-human clinical trial is evaluating the safety, tolerability, pharmacokinetic and pharmacodynamic properties and preliminary efficacy of IDE161 in patients having solid tumors with homologous recombination deficiency or HRD.
IDEAYA owns or controls all commercial rights in IDE161, subject to certain economic obligations under its exclusive, worldwide license with Cancer Research UK and University of Manchester.
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