The European Commission (EC) has designated lurbinectedin as an orphan drug 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, which represent 16% of this type of tumors, and more frequently affect adults from middle age onwards, predominating among women.

The orphan drug designation is a status granted by the EMA to those drugs intended to treat rare or unusual diseases, which affect less than five 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 is expected to benefit patients with the disease.

This type of 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 ten years. in the European Union.

Lurbinectedin has been approved by the American Food and Drug Administration (FDA) since June 2020 for the treatment of relapsed small cell lung cancer, the type of tumor with the fewest treatment options.. A use for which it also has approval in countries such as the United Arab Emirates to Australia, passing through Singapore, Canada, South Korea or Mexico, and is pending the approval of the EMA in this same disease.

PharmaMar, for its part, already has another medicine in its portfolio approved for the treatment of sarcoma, trabectedin, to which this new designation would come to be added in the fight against this rare cancer.