IDE161 is now eligible for inclusion in a development program allowing for expediated regulatory review following its FDA fast track designation status for advanced BRCA1/2-mutant ovarian cancer.
The FDA has granted fast track designation to IDE161 for the treatment of patients with BRCA1/2-mutant advanced or metastatic ovarian cancer that is platinum resistant and was previously treated using an antiangiogenic agent and a PARP inhibitor, according to a press release from Ideaya Biosciences.1
IDE161, a potent, selective PARG inhibitor, is being evaluated as part of a phase 1 study (NCT05787587) in those diagnosed with homologous recombination deficient (HRD)–positive solid tumors, including patients with ovarian cancer.
“We are extremely pleased to receive the U.S. FDA fast track designation for IDE161 based on the FDA's review of preclinical and emerging clinical efficacy and tolerability data,” Darrin Beaupre, MD, PhD, MS, chief medical officer at Ideaya Biosciences, said in the press release. “We recently reported preliminary clinical proof-of-concept with expansion into priority HRD-[positive] 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.”
IDE161 also received fast track designation for breast cancer that is advanced or metastatic, as well as hormone receptor positive, HER2 negative, and BRCA1/2 mutant.2