Idience, a novel anticancer drug developer under the Ildong Pharmaceutical Group, announced on the 18th that its targeted cancer drug candidate ‘Venadaparib’ has received Fast Track designation from the U.S. Food and Drug Administration (FDA).
According to Idience, Fast Track is an expedited program intended to facilitate the development and review of drugs for serious conditions that may provide meaningful advantages over existing therapies or address unmet medical needs.
With Fast Track designation, a sponsor can communicate more frequently with the FDA throughout development and the review process, and may be eligible for expedited pathways such as rolling submission of sections of an application (rolling review) and consideration for Priority Review.
Venadaparib is designed to inhibit cancer growth by selectively targeting PARP1 (poly[ADP-ribose] polymerase 1), an enzyme involved in repairing DNA damage in cells. In 2022, the FDA also granted Venadaparib orphan drug designation for the treatment of gastric cancer. A Phase 1b/2a clinical trial evaluating Venadaparib in combination with irinotecan is currently underway in gastric cancer patients in South Korea and the United States.
Lee Won-sik, CEO of Idience, said, “This Fast Track designation is highly meaningful in that the FDA has recognized Venadaparib’s clinical potential and its ability to help address unmet medical needs,” adding, “We will do our utmost to accelerate our global clinical development and deliver a new treatment option.”
