Idience's Targeted Anticancer Drug Venadaparib Receives FDA 'Fast Track' Designation

Expedited Development and Regulatory Review Process Expected for Gastric Cancer Combination Therapy

Idience (CEO Won-sik Lee), Ildong Pharmaceutical Group's specialized anticancer drug development company, has received 'Fast Track Designation' from the U.S. Food and Drug Administration (FDA) for its targeted anticancer drug candidate 'Venadaparib'.

'Fast Track' is one of the FDA's expedited review programs designed to facilitate the rapid and smooth development of drugs that have the potential to offer meaningful improvements over existing treatments or address unmet medical needs in serious conditions. Idience explains that upon receiving Fast Track Designation, close consultations with the FDA become possible throughout the drug development and regulatory approval process, and expedited procedures such as Rolling Review and Priority Review applications can be expected.

Venadaparib is a next-generation PARP inhibitor that selectively targets PARP1 (Poly ADP-ribose polymerase 1) — an enzyme involved in repairing cellular DNA damage — to suppress cancer, and was previously designated by the FDA as a treatment for gastric cancer-related rare diseases in 2022.

Various studies are currently underway in South Korea and the United States targeting gastric cancer patients, including Phase 1b/2a clinical trials aimed at optimizing dosage and securing safety and efficacy data, with the goal of developing a combination therapy utilizing Venadaparib and Irinotecan.

According to research results presented at the American Society of Clinical Oncology (ASCO) last year, interim data from patients with metastatic gastric cancer (mGC) receiving third-line or later treatment demonstrated outstanding efficacy with the Venadaparib and Irinotecan combination therapy, including more than doubling the median Progression-Free Survival (mPFS) compared to existing standard treatments.

CEO Won-sik Lee of Idience stated, "This Fast Track Designation carries great significance in that the FDA has recognized Venadaparib's clinical potential and its capacity to address unmet medical needs. We will do our utmost to accelerate global clinical development efforts and present new treatment options."