Yondelis given orphan drug status by the European Commission

Published: 24-Oct-2003

Yondelis (formerly ET-743), the marine-derived lead compound of Madrid-based PharmaMar, has been granted orphan drug status for the treatment of ovarian carcinoma by the European Commission following adoption of a positive opinion by the Committee for Orphan Medicinal Products (COMP) of the European Agency for the Evaluation of Medicinal Products (EMEA).


Yondelis (formerly ET-743), the marine-derived lead compound of Madrid-based PharmaMar, has been granted orphan drug status for the treatment of ovarian carcinoma by the European Commission following adoption of a positive opinion by the Committee for Orphan Medicinal Products (COMP) of the European Agency for the Evaluation of Medicinal Products (EMEA).

In ongoing Phase II clinical studies at the Southern European New Drugs Organization (SENDO) Research Centre, Yondelis has already shown encouraging activity in women with advanced ovarian carcinoma: 46% of patients with relapsing disease following previous platinum-taxane treatment achieved objective responses. Phase I clinical trials of Yondelis in combination with cisplatin, carboplatin and taxanes are currently ongoing.

  

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