Yondelis trabectedin regulatory update

The U.K.'s NICE referred an appraisal of Yondelis trabectedin to treat relapsed ovarian cancer back to the appraisal committee after the Department of Health approved a patient access scheme submitted by PharmaMar following a final appraisal determination (FAD) issued last year. In the FAD, NICE recommended against the use of Yondelis in combination with pegylated liposomal doxorubicin hydrochloride (PLDH) to treat relapsed ovarian cancer - its approved indication. NICE had said that the data submitted by the company were not robust enough because the company did not compare Yondelis to re-treatment with platinum-based chemotherapy, the preferred option for relapsed platinum-sensitive disease (see BioCentury, Sept. 27, 2010). ...