FDA panel recommends against Centocor’s trabectedin (ovarian cancer)

The Food and Drug Administration’s Oncologic Drugs Advisory Committee voted Wednesday not to recommend approval of trabectedin, an experimental cancer treatment being developed by Centocor Ortho Biotech.

Centocor Ortho Biotech of Horsham, Pa., is seeking approval of trabectedin as part of a combination therapy with the cancer drug Doxil for patients with relapsed ovarian cancer.

FDA committee recommendations are nonbinding, but the federal agency generally follows the advice of its advisory panels when making a final determination......Under a licensing agreement with PharmaMar SAU of Spain, Centocor has worldwide marketing rights for trabectedin except in Europe and Japan, where the product is marketed as Yondelis by PharmaMar.