Taiwan Liposome's TLC178 Receives EMA's ODD for Soft Tissue Sarcoma (STS)
Shots:
- The ODD follows P-I/II study assessing TLC178 in patients with advanced malignancies in adults and has resulted in no dose-limiting toxicity till date
- The EMA’s Orphan Drug Designation (ODD) is granted to the therapies offering life-threatening condition affecting ≤5 in 10-000 persons in EU- with no approved treatment and receiving 10-year of marketing exclusivity in EU on approval
- TLC178 is a liposomal formulation of vinorelbine (a chemotherapy drug) based on Taiwan’s NanoX technology and has received FDA’s Rare Pediatric Disease Designation for RMS in April 2017
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