PharmaMar (PHM: MSE) has announced that lurbinectedin has been designated an Orphan Drug by the European Commission for the treatment of soft tissue sarcoma, following the positive opinion of the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA).

Soft tissue sarcoma is a rare type of cancer. Currently, one of the most common subtypes of sarcoma are leiomyosarcomas (LMS), which represent 16% of this pathology, and more frequently affect middle-aged adults and older, predominating among women.

The orphan drug designation is a status granted by the EMA to medicines intended to treat rare or uncommon diseases, which affect less than 5 people per 10,000 inhabitants in the European Union. To earn this designation, the drug must demonstrate its ability to treat a disease that does not have satisfactory therapeutic options, and the drug is expected to benefit patients with 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.

Contact:

Tel: +34 91 846 6000

Fax: 91 846 6001

Email: pharmamar@pharmamar.com

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