* U.S. panel says toxicity risks likely outweigh benefit
* Votes 14-1 against FDA approval of Yondelis
NEW YORK, July 15 - A Johnson & Johnson and Zeltia SA drug for ovarian cancer should not be approved, as risks of heart and liver toxicity outweigh its limited ability to keep the disease in check, an advisory panel to the U.S. Food and Drug Administration said on Wednesday.
While the rejection is relatively inconsequential for giant healthcare conglomerate J&J, it represents a major setback for Spanish biotechnology company Zeltia.
Yondelis, known chemically as trabectedin, was approved for the treatment of recurrent ovarian cancer in the Philippines last week, raising hopes it would get a favorable reception from the U.S. panel.
But panelists overwhelmingly felt that the 6-week benefit in progression-free survival shown in a pivotal late-stage clinical trial did not justify approval. The trial tested Yondelis plus Doxil chemotherapy versus Doxil alone.
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