FDA Questions Effectiveness of Proposed J&J Cancer Drug, Yondelis

Study findings for a new Johnson & Johnson and Zeltia drug for women with ovarian cancer are being questioned by authorities at the Food and Drug Administration.

The FDA reportedly will ask a board of advisers to consider whether the drug Yondelis is effective and safe enough to earn approval. Discrepancies in radiology readings from a study of the drug caused the agency to question how the study was conducted and seek further input on how the status of women examined was measured, according to a Reuters news report.

The study in question examined how long it took for the cancer to advance in patients treated with a cocktail of Yondelis and another J&J cancer drug, Doxil. Doxil is approved for use in the United States, but Yondelis is not.

In the study, the combination of Doxil and Yondelis resulted in a decrease in white blood cells that can make patients vulnerable to infections, the FDA said. Also, cardiac problems were higher in patients who received Yondelis.

The cocktail of cancer-fighting drugs result in “modest improvement” in the duration of time before the cancer started growing, but produced no improvement in overall survival, FDA said. Also, the treatment was “poorly tolerated” and 34 percent of patients stopped taking Doxil due to side effects.

FDA staffers said an advisory panel of medical experts will be asked to review the study findings and determine if they are reliable and clinically significant and whether the risks of Yondelis do not outweigh its benefits. The panel will be asked for its opinion on expanding the use of Doxil as well as the approval of Yondelis.

While the FDA is not obligated to follow the recommendations of its advisory panels, in most cases, it does.

News of the heightened FDA review of the Doxil-Yondelis research was seen as bad news for a new drug application that most observers had predicted would move through the FDA without little or no roadblocks.

Johnson & Johnson has said the combination of Yondelis and Doxil would provide a safe and effective treatment option, particularly for women with ovarian cancer relapses who are not candidates to take other platinum-based cancer regimens.

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