Scrip World Pharmaceutical News - Yondelis to be filed for ovarian cancer after Phase III success
 
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Yondelis to be filed for ovarian cancer after Phase III success

Wednesday 13 August 2008
Malini Guha - Science Editor

PharmaMar's anticancer Yondelis (trabectedin) has succeeded in extending progression-free survival (PFS) in its pivotal Phase III trial in relapsed ovarian cancer, and the Spanish company and its US partner Ortho Biotech (Johnson & Johnson) will seek both EU and US approval before the end of the year for this important indication.

PFS was the primary endpoint of the 650-patient ET743-OVA-301 trial. Secondary endpoints included overall survival, response rate and safety. PharmaMar (a subsidiary of Zeltia) was unable to comment on any of these...


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