FDA Grants Fast Track Designation for New Breast Cancer Treatment

The U.S. Food and Drug Administration (FDA) has released a new fast track designation for IDE161, an inhibitor of poly (ADP-ribose) glycohydrolase (PARG) to treat adult patients with advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor 2 receptor (HER2)-negative breast cancer.

Patients within this population have germline or somatic BRCA ½ mutations that have progressed following treatment with at least one line of hormonal therapy, an inhibitor (CDK4/6) therapy and a poly polymerase (targets proteins)(PARP) inhibitor therapy, according to a press release from BioSpace.

"The U.S. FDA Fast Track designations for our potential first-in-class PARG inhibitor, IDE161, in both BRCA1/2-mutant breast and ovarian cancers reflect the potential for IDE161 to address the significant unmet medical need in these indications," Dr. Darrin Beaupre, chief medical officer at Ideaya Biosciences, said in a recent news release.

Ideaya is a medical oncology company that focuses on the development of new targeted therapeutics within patient. Patient populations are investigated to apply research and target the correct molecular diagnostic.

The trial had a focus on patients with estrogen receptor (ER) positive, HER2-negative, homologous recombination deficiency (HRD)-positive tumors, according to the news release.

“The name “BRCA” is an abbreviation for “BReast CAncer gene.” BRCA1 and BRCA2 are two different genes that have been found to impact a person’s chances of developing breast cancer,” according to The National Breast Cancer Foundation.

The Fast Track process by the FDA confirmed an efficiency and speedy review of IDE161, typically to fill an unmet need within a serious condition. In this case, IDE161 is eligible for more recognition within FDA discussions and potential approval of a New Drug Application (NDA).

A phase 1 trial is put in place for IDE161 to analyze the treatment of solid tumors in patients with HRD, patients with BRCA ½ mutant endometrial and colon cancer.

That trial will then expand to patients with HRD-positive breast and ovarian cancer, alongside other tumors.

Ideaya plans on updating the public in the fourth quarter of 2023 to ensure the therapeutic benefits, risks and uncertainties of IDE161 have been fully investigated.

"We are excited that IDE161 has been granted Fast Track status in two separate indications, and we look forward to providing further program updates for IDE161 in the fourth quarter of this year," noted Beaupre in the news release.

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