Jul 20, 2017
TLC Receives Orphan Drug Designation by US FDA of TLC178 for the Treatment of Soft Tissue Sarcoma
TLC (4152:TT) announced that its oncology product candidate TLC178 has received an orphan drug designation for the treatment of soft tissue sarcoma by the U.S. Food and Drug Administration (FDA). A Phase 1/2a dose-escalation study has been underway at sites in Taiwan and the U.S. to evaluate the maximum tolerated dose of the drug to be used in pivotal studies. In April this year, the FDA designated TLC178 as a drug for a rare pediatric disease in the treatment of rhabdomyosarcoma, a type of soft tissue sarcoma.
The American Cancer Society estimates about 12,000 new cases of soft tissue sarcomas to be diagnosed in the U.S. this year. Soft tissue sarcomas are a group of rare cancers affecting the tissues that connect, support and surround other body structures and organs. Treatment for soft tissue sarcoma includes surgery, radiation, and chemotherapy. TLC178 is a liposomal-encapsulated formulation of the chemotherapy drug vinorelbine that applies the NanoX™ nanotechnology platform to decrease toxicity and reduce side effects. These capabilities allow extended applications from the current vinorelbine indications to advanced solid tumors such as soft-tissue sarcoma.
“This most recent designation from the FDA indicates the potential of TLC178 for an additional indication within oncology,” commented George Yeh, President of TLC. “We are looking forward to the next steps in development of TLC178, which we expect to discuss with U.S. regulators soon.”
In April this year, TLC178 was designated as a drug for a rare pediatric disease in the treatment of rhabdomyosarcoma, which is the most common type of soft tissue sarcoma seen in children. The April designation qualifies TLC178 for a Rare Pediatric Disease Priority Review Voucher, which can significantly shorten the marketing application review period from over ten months to just six months. If TLC178 is approved for the treatment of pediatric rhabdomyosarcoma, the orphan drug designation will broaden its indication to soft tissue sarcomas and provide an orphan drug exclusivity of 7 years.
Source： Taiwan Liposome Company, Ltd.
http://www.tlcbio.com/en-global/MediaDownloadContent/media_download/Content/90