ARTICLE | Clinical News

Yondelis trabectedin regulatory update

September 27, 2010 7:00 AM UTC

The U.K.'s NICE issued a final appraisal determination (FAD) recommending against the use of Yondelis trabectedin in combination with pegylated liposomal doxorubicin hydrochloride (PLDH) to treat relapsed ovarian cancer - its approved indication. The recommendation is in line with a June preliminary appraisal (see BioCentury, June 21). NICE said the data submitted were not robust because the company did not compare Yondelis to re-treatment with platinum-based chemotherapy, the preferred option for relapsed platinum-sensitive disease. PharmaMar compared Yondelis plus PLDH against PLDH, paclitaxel and topotecan as monotherapy. ...