US FDA grants orphan drug status to TLC178 to treat cutaneous T-cell lymphoma

Taipei City Friday, October 21, 2016, Taiwan Liposome Company (TLC) announced that product candidate TLC178 has been granted an orphan drug designation for the treatment of cutaneous T-cell lymphoma (CTCL) by the US 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 US, 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 US 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.

Comments: a typical and another example to use liposomes to increase the therapeutic index of generic oncology drugs to develop line extension products.