Taiwan Liposome Company (TLC) Release: TLC178 Granted Orphan Drug Designation By U.S. FDA For The Treatment Of Cutaneous T-cell Lymphoma (CTCL)
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).
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.
TLC178 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.
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.
TLC178 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.