Rznomics announced on the 14th that its anticancer drug, RZ-001, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of Hepatocellular Carcinoma (HCC).
The Fast Track program, established by the FDA, supports the development of drugs for serious or life-threatening diseases by expediting the approval process. Once a drug is designated and if relevant criteria are met, it benefits from accelerated review and approval, as well as more frequent and flexible communication with the FDA. Additionally, during the Biologics License Application review, a rolling review can be conducted for each data section, providing an advantage in the evaluation process.
RZ-001 is an anticancer drug developed using Trans-splicing Ribozyme, Rznomics‘ proprietary RNA editing platform technology. It has received Investigational New Drug (IND) approval from both South Korea’s Ministry of Food and Drug Safety (MFDS) and the U.S. FDA. Currently, it is in Phase 1b/2a clinical trials for Hepatocellular Carcinoma (HCC) and Phase 1/2a trials for Glioblastoma (GBM).
Furthermore, for Glioblastoma (GBM), RZ-001 has been approved under the FDA’s Expanded Access Program (EAP), which allows compassionate use of investigational treatments outside clinical trials. The program is currently being conducted at Harvard University Hospital.
