CrystalGenomics Designated for Priority Review of Pancreatic Cancer Treatment 'Ivaltinostat'

[Asia Economy Reporter Oh Ju-yeon] CrystalGenomics announced on the 9th that its pancreatic cancer treatment drug 'Ivaltinostat' has been designated as the first anticancer drug new drug to be subject to expedited review by the Ministry of Food and Drug Safety (MFDS).

Through this designation as an expedited review target, Ivaltinostat will be able to shorten the period until new drug approval.

Drugs designated for expedited review complete the review results within 90 days during the new drug approval review. In addition, the MFDS stipulates priority review and pre-consultation for drugs subject to expedited review, providing the advantage of simultaneously enhancing the speed and accuracy of new drug approval.

The designation of Ivaltinostat as an expedited review target is significant as it is the first anticancer drug candidate developed by an innovative pharmaceutical company to receive such designation.

Previously, the MFDS established the 'Expedited Review System,' similar to the U.S. Food and Drug Administration (FDA)'s Fast Track, and reorganized the responsible organization to shorten the product development period of pharmaceuticals while expanding treatment opportunities for safe and new medical products.

In particular, pancreatic cancer is a difficult-to-treat cancer type with a market value expected to reach $2.3 billion by 2026, yet currently lacks adequate treatment options.

Ivaltinostat is an epigenetic disease-targeting HDAC inhibitor, and in a phase 2 clinical trial for advanced or metastatic pancreatic cancer conducted at Yonsei University College of Medicine's Severance Hospital in Sinchon, it demonstrated superior safety and efficacy compared to existing standard treatments, indicating high growth potential.

Currently, CrystalGenomics' Ivaltinostat is also focusing on expanding indications to other cancer types such as hepatocellular carcinoma (HCC) and myelodysplastic syndrome (MDS), as well as chronic diseases like fibrosis, based on its excellent safety profile.

As late-stage clinical trials for pancreatic cancer are approved and proceed, the expansion of indications to other diseases will accelerate, further highlighting the value of Ivaltinostat's multiple pipelines.

A CrystalGenomics representative stated, “Through the expedited review designation, we expect that Ivaltinostat as a first-line treatment for pancreatic cancer will be able to become a new treatment option sooner for patients with inoperable advanced or metastatic pancreatic cancer.”

This content was produced with the assistance of AI translation services.