The U.S. Food and Drug Administration (FDA) has granted fast track designation to ETX-19477, an oral treatment for ovarian cancer currently in early clinical testing.
The FDA grants this designation to investigational drugs intended to treat serious or life-threatening conditions and address unmet medical needs. The goal is to accelerate the development of important new therapies. ETX-19477’s developer, 858 Therapeutics, will gain access to benefits including more frequent communication with the FDA throughout the drug development process.
The designation covers ETX-19477’s use in people with high-grade serous ovarian cancer (HGSOC) that carries a BRCA mutation and is resistant to standard platinum-based chemotherapies. HGSOC is a form of gynecological cancer that develops due to the abnormal growth of cells around the ovaries, and treatment options are limited for patients who don’t respond to platinum-based chemotherapy.
Options limited for those with platinum-resistant ovarian cancer
“Patients with platinum-resistant ovarian cancer have a poor prognosis, and treatment options remain extremely limited, highlighting a substantial unmet need for new therapies,” Jeffrey Stafford, PhD, CEO of 858 Therapeutics, said in a company press release. “We are pleased that the FDA has granted Fast Track designation to ETX-19477 and we are committed to working closely with the FDA to accelerate its development.”
BRCA mutations disrupt a cell’s ability to properly repair DNA damage, which can increase the risk of various cancers. ETX-19477 is designed to block the activity of a DNA repair enzyme called PARG. In cancer cells with BRCA mutations, blocking PARG causes irreparable DNA problems that ultimately lead to cell death.
A Phase 1/2 clinical trial (NCT06395519) is testing ETX-19477 in people with various types of solid tumors, including ovarian cancer. The study is giving preference to participants with BRCA mutations, though this isn’t a requirement for enrollment. The trial’s main goal is to assess the safety profile of ETX-19477. The study is recruiting participants at a dozen sites across the U.S.
Stafford said the FDA’s decision to grant ETX-19477 fast track designation “was based on preclinical data and emerging clinical data from our ongoing Phase 1/2 trial of ETX-19477, including anti-tumor activity at tolerable doses.”
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