The US Food and Drug Administration (FDA) voted against recommending approval for Yondelis (trabectedin) for ovarian cancer in July 2009. The drug was submitted by partner Johnson & Johnson (J&J).
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 14-1 against approval of Zeltia’s Yondelis for the treatment of relapsed ovarian cancer, in combination with J&J’s Doxil/Caelyx (doxorubicin). The drug was shown to have a six-week benefit in progression-free survival in a Phase III trial, but the panel decided this does not justify the use of the drug.
The ODAC also noted that there was a notable increase in severe and life-threatening adverse events in the Yondelis treatment group, including more than twice as many pulmonary embolisms, three times more cardiac adverse events and a higher rate of liver enzyme increases.
J&J’s Centocor Ortho Biotech unit said that it still believes trabectedin “has an important role in the treatment of recurrent ovarian cancer” and “remains committed to working with the FDA to address the committee’s concerns".
Further reading - An in-depth analysis of the US pharmaceutical market is available from Espicom: The Pharmaceutical Market: USA (published June 2009)