FDA grants fast track status to SRF388 for hepatocellular carcinoma
The FDA granted fast track designation to SRF388 for treatment of certain patients with hepatocellular carcinoma, according to the agent’s manufacturer.
The designation applies to use of SRF388 (Surface Oncology) by patients previously treated with standard therapies, such as VEGF-targeted agents and PD-L1 blockade.
“Liver cancer is the most rapidly increasing type of cancer in both men and women in the U.S., with incidences tripling since 1980,” Rob Ross, MD, chief medical officer of Surface Oncology, said in a company-issued press release. “There is a significant need to expedite the development of new therapies to treat liver cancer, as the 5-year survival for patients with unresectable or metastatic liver cancer is less than 5%.”
SRF388 is a fully human anti-interleukin-27 antibody. IL-27, an immunosuppressive cytokine, has been found to be elevated among patients with liver cancer and kidney cancer.
Enrollment is underway for a phase 1 monotherapy dose-escalation study that will evaluate SRF388 for patients with advanced solid tumors, with planned expansions in liver cancer and kidney cancer to evaluate the agent as monotherapy and in combination with other treatments.
The FDA previously granted orphan drug designation to SRF388 for treatment of HCC.
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.