On May 12, 2023 PharmaMar (PHM:MSE) reported that the European Commission has designated lurbinectedin as an Orphan Medicinal Product for the treatment of Soft Tissue Sarcoma (STS), following a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) (Press release, PharmaMar, MAY 12, 2023, View Source [SID1234631601]).

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STS is a rare type of cancer. Currently, one of the most common subtypes of sarcoma is Leiomyosarcoma (LMS), which accounts for 16% of the pathology, and most frequently affects middle-aged adults and older, predominantly women.

Orphan drug designation is a status granted by the EMA to drugs intended to treat rare or uncommon diseases that affect fewer than 5 people per 10,000 inhabitants in the European Union. To obtain this designation, the drug must demonstrate its ability to treat a disease, that has no satisfactory therapeutic options and is expected to benefit patients suffering from the disease. Orphan drug designation offers several benefits to drug manufacturers, including exemption from some EMA fees, scientific and regulatory advice during drug development, and the possibility of receiving tax benefits and market exclusivity for a period of 10 years in the European Union.