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FDA Brief: Fast Track Designation Granted to STAT3 Inhibitor in Liver Cancer

By: JNCCN 360 Staff
Posted: Friday, October 21, 2022

On October 19, 2022, the biopharmaceutical company Tvardi Therapeutics, Inc. announced that its product TTI-101 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory locally advanced, unresectable, or metastatic hepatocellular carcinoma. TTI-101 is an orally delivered, small molecule, STAT3 inhibitor.

TTI-101 is completing a first-in-human phase I trial of patients with advanced solid tumors (including hepatocellular carcinoma) who have failed to respond to other lines of therapy. Patients will soon be enrolled in a phase II hepatocellular carcinoma basket trial, which will test TTI-101 as monotherapy and in combination with existing approved therapies across first-, second-, and last-line settings for patients with hepatocellular carcinoma. To date, according to the manufacturer, TTI-101 monotherapy has been well tolerated and has demonstrated clinical activity across a broad range of tumors, including multiple durable radiographic objective responses.

To learn more about the ongoing clinical trial in hepatocellular carcinoma, please visit

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