Advisory Panel Says FDA Should Reject J&J Cancer Drug Yondelis

A panel of cancer experts who advise the Food and Drug Administration on whether to approve new drugs has given a big fat thumbs down to Yondelis, the proposed Johnson & Johnson and Zeltia SA ovarian cancer drug.

Earlier this week, citing troubling discrepancies in radiology results and other aspects of a crucial clinical study of Yondelis, FDA officials said they questioned the safety and effectiveness of the proposed new drug. They said they’d ask an advisory panel for its opinion and they got it today.

By an overwhelming vote of 14-1, the panel recommended the agency reject Yondelis. While the FDA is not bound to follow the advice of its panel, it most often does. A final ruling on Yondelis is expected in the coming weeks.

Yondelis, also called by its generic name trabectedin, recently was approved for the treatment of recurrent ovarian cancer in the Philippines. That raised hopes about a positive outcome of the FDA panel meeting about the drug. Not so much.

The panel members said the fact that Yondelis was found in a key late-stage clinical trial to provide cancer sufferers with six weeks of progress-free survival when given with another cancer drug was not enough to tip the scales in its favor. In that study, Yondelis was tested in combination with Doxil and compared to cancer progression results for people given only Doxil.

J&J and its Yondelis partner aren’t ready to throw in the towel on the drug yet. In a statement issued in response to the advisory panel vote to reject Yondelis, J&J’s Centocor Ortho Biotech unit said it is committed to working with the FDA to address the committee’s concerns and still believes that “trabectedin has an important role in the treatment of recurrent ovarian cancer.”

The one panelist who voted for approving Yondelis said “it does look like there is a relatively small but significant group who could benefit from this,” according to a Reuters news report.

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