FDA Grants Orphan Drug Designation for TLC178 for Cutaneous T-Cell Lymphoma

The FDA granted orphan drug designation to the investigational drug TLC178, a liposomal-encapsulated formulation of the chemotherapy drug vinorelbine for patients with cutaneous T-cell lymphoma (CTCL). This formulation applies a nanotechnology platform to decrease the toxicity of the drug. A phase I/II open-label, dose-escalation study of the safety, tolerability, and pharmacokinetics of intravenous TLC178 in patients with CTCL and other lymphomas is planned for sites in Taiwan and the United States.

Source: TLC press release, October 26, 2016.