10 diciembre 2013

Yondelis Fase III Ovario EEUU . Myriad, Janssen R&D Using BRACAnalysis in Phase III Study for Yondelis .

Janssen Will Use Myriad's BRCA Test in Phase 3 Trial .
Mon, 12/09/2013 - 1:35pm .


NEW YORK (GenomeWeb News) – Myriad Genetics and Janssen Research & Development today announced they will use Myriad's BRACAnalysis test in a Phase III clinical trial for Yondelis (trabectedin).

Janssen is developing Yondelis as a treatment for advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancers. The firm is studying the drug in combination with a chemo regimen in the third-line setting comparing it against just chemotherapy in patients who have had two previous lines of platinum-based chemo.

Myriad has a number of collaborations with drug developers using BRACAnalysis to identify best responders in clinical trials investigating PARP inhibitors. It has inked deals with AstraZeneca, BioMarin, and Tesaro to use the test to identify patients that will benefit from drugs in Phase III trials.

Yondelis is already available in Europe, Russia, and South Korea as a treatment for advanced soft tissue sarcoma. European regulators and the US Food and Drug Administration have granted orphan drug status to Yondelis for soft tissue sarcomas and ovarian cancer.