TLC178 Granted Orphan Drug Designation by US FDA for the Treatment of Cutaneous T-cell Lymphoma

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Credit: Pixabay
Credit: Pixabay

Taiwan Liposome Company (TLC) (4152:TT) today announced that product candidate TLC178 has been granted an orphan drug designation for the treatment of cutaneous T-cell lymphoma (CTCL) by the U.S. Food and Drug Administration (FDA).

(An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease.)

Lymphoma is the most common blood cancer. The two main forms of lymphoma are Hodgkin’s lymphoma and non-Hodgkin’s lymphoma (NHL).  T-cell lymphomas account for approximately 15 percent of all cases of NHL in the U.S., with cutaneous T-cell lymphoma being one of the most common forms of T-cell lymphoma.

logo19TLC178 is a liposomal-encapsulated formulation of the chemotherapy drug vinorelbine that applies the NanoX™ nanotechnology platform to decrease the toxicity of the drug.  Lower toxicity is likely to expand applications for TLC178 from the current vinorelbine indications of non-small cell lung cancer (NSCLC) to lymphomas and other advanced solid tumors.

TLC has recently received US FDA approval for its Phase 1/2 open-label, dose-escalation study investigating the safety, tolerability and pharmacokinetics of intravenous TLC178 administration.  This Phase 1/2 clinical trial is planned for sites in both Taiwan and the U.S.  Trial in Taiwan will be initiated once approval is granted by the Taiwan FDA.

According to a recent report from GBI Research, the global market for the treatment of non-Hodgkin’s lymphoma is expected to reach $9.2 billion by 2020, reflecting a compound annual growth rate (CAGR) of 7.4% from a market of $5.6 billion in 2013.