Yondelis trabectedin regulatory update

The U.K.'s NICE issued a preliminary appraisal recommending against the use of Yondelis trabectedin from PharmaMar in combination with pegylated liposomal doxorubicin (PLDH) to treat patients with relapsed platinum-sensitive ovarian cancer - its approved indication. The agency said the data submitted were not robust because the company did not compare Yondelis against paclitaxel in combination with platinum-based chemotherapy, a "gold-standard" treatment for the indication. In its submission, PharmaMar compared Yondelis plus PLDH against PLDH, paclitaxel and topotecan as monotherapy. Comments are due by July 8.

In February, NICE issued final guidance recommending the use of Yondelis to treat advanced soft tissue sarcoma when treatment with anthracyclines and ifosfamide has failed or patients are intolerant of, or have contraindications to, the therapies(see BioCentury, March 1). GlaxoSmithKline plc (LSE:GSK; NYSE:GSK, London, U.K.) markets Hycamtin topotecan. ...