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

Expedited Development and Approval Review Expected for Gastric Cancer Combination Therapy

Idience, an anticancer drug development company under Ildong Pharmaceutical Group, announced on the 18th that its novel targeted anticancer drug candidate, "Venadaparib," has received "Fast Track" designation from the U.S. Food and Drug Administration (FDA).

The headquarters of Ildong Pharmaceutical Group. Ildong Pharmaceutical

The Fast Track program is a rapid review process operated by the FDA for drugs that show the potential for meaningful improvement over existing treatments in serious diseases or that can address areas of unmet medical need. According to the company, Fast Track designation allows for close consultation with the FDA during drug development and approval processes, as well as the application of expedited procedures such as rolling submissions of data and requests for priority review.

Venadaparib is a next-generation PARP inhibitor that selectively targets the DNA damage repair enzyme PARP1 to suppress cancer. In 2022, it was also designated as an orphan drug for gastric cancer by the FDA.

Currently, a Phase 1b/2a clinical trial combining Venadaparib with the anticancer drug Irinotecan is underway in Korea and the United States for patients with gastric cancer. The trial aims to optimize dosage and secure safety and efficacy data.

According to research results presented at the American Society of Clinical Oncology (ASCO) last year, interim data for patients with metastatic gastric cancer (mGC) who had undergone at least third-line treatment showed that combination therapy with Venadaparib and Irinotecan more than doubled the median progression-free survival (mPFS) compared to existing standard therapies.

Wonshik Lee, CEO of Idience, stated, "The Fast Track designation is significant as it acknowledges Venadaparib’s clinical potential and its ability to address unmet medical needs, as recognized by the FDA. We will do our utmost to accelerate global clinical development and provide new treatment options."

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