FDA Grants Orphan Drug Designation to Treatment of Peripheral T-Cell Lymphoma
Posted: Friday, August 24, 2018
The U.S. Food and Drug Administration (FDA) recently granted Orphan Drug designation to CPI-613 for the treatment of peripheral T-cell lymphoma. CPI-613 is a novel lipoic acid analog with an anticancer activity that inhibits multiple enzyme targets within the tricarboxylic acid cycle.
CPI-613 is currently under investigation in combination with bendamustine in patients with relapsed or refractory T-cell lymphoma. The interim results with this combination therapy in patients with T-cell lymphoma revealed an 86% objective response rate (half complete responses and half partial responses).
The primary objective of the current study is to determine the maximum tolerated dose and safety profile of CPI-613 when used in combination with bendamustine to treat patients with relapsed or refractory T-cell lymphoma or classical Hodgkin lymphoma. Abramson Cancer Center of the University of Pennsylvania has been announced as the second clinical trial site for this study.
