Yondelis filing preparation continues
Global health care giant Johnson & Johnson and Spain's PharmaMar, a subsidiary of the Zeltia Group, say that preparations for the regulatory filing of their co-developed anticancer agent Yondelis (trabectedin) are continuing. The drug, which is based on a compound originally isolated from the marine tunicate Ecteinascidia turbinata, is believed to interfere with cellular processes at the DNA level via several as yet uncharacterized mechanisms.
The companies went on to say that they had been working closely with regulatory authorities, with the aim of submitting data from Phase II trials of the drug to the European Medicines Agency (EMEA) and the US Food and Drug Administration as a treatment for soft tissue sarcoma for which Yondelis received Orphan Drug designation from the European Commission in 2001 and from the FDA in 2004, when a planned Phase III confirmation trial is underway.
In addition, the drug is being assessed for use in the treatment of ovarian, prostate and breast cancers and is at the Phase II/III trial stage for each indication.
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