Reuters has just issued an update on Eli Lilly's announcement that the U.S. Food and Drug Administration, FDA, approved the use of Gemzar in the treatment of recurrent ovarian cancer, questioning why the company omitted information that the FDA approval goes against the advice of an FDA advisory panel earlier this year that strongly recommended against approval of the drug for this use. The FDA approved use of Gemzar in combination with carboplatin, in chemotherapy treatment for women with advanced ovarian cancer that has relapsed at least six months after initial therapy. The reason the FDA advisory panel voted against the approval of the use of Gemzar in combination with carboplatin, were due to questions raised about Lilly's trial data and the way the company conducted the 356-person clinical study. The panel was concerned that patients in the late-stage clinical trial failed to survive longer than those taking carboplatin alone. The FDA went ahead and approved it after the drug company provided additional information.
What needs to be made clear is that Gemzar does not seem to prolong the life of women with recurrent ovarian cancer, and the drug company is only stating that Gemzar provides longer progression-free survival than patients taking carboplatin alone. Progression-free survival measures the time before the disease recurs or worsens.
According to Reuters, when a spokesperson for Lilly was asked why they did not mention in its release that the FDA advisory panel had voted against the approval of Gemzar, or the drug's failure to prolong life, he said, "I'm not sure that needed to be the focus."


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