FDA Halts Telik's Telcyta
The Food and Drug Administration has ordered biotech firm Telik (TELK) to stop all clinical trials of its experimental cancer drug Telcyta after data released this weekend showed the drug hastened the deaths of women with advanced ovarian cancer.
In a press release issued late Monday night, Telik said the FDA ordered the company to halt enrollment in all ongoing Telcyta trials. Furthermore, no patients currently being treated in the trials will be allowed to receive additional Telcyta.
Telik did not give a reason for the FDA action, except to say that the directive came after the company presented Telcyta data from phase III clinical trials at the annual meeting of the American Society of Clinical Oncology (ASCO).
In December, Telik announced that one of those trials -- dubbed Assist-1 -- had failed to show that Telcyta could improve the overall survival of women with advanced ovarian cancer compared to currently approved drugs.But it wasn't until Sunday at an ASCO poster session -- more than five months later -- that Telik disclosed publicly just how badly Telcyta performed in the Assist-1 study. The woman treated with Telcyta died more than five months faster than similar woman in the control arm of the study. The median survival time for women in the Telcyta arm of Assist-1 was 8.5 months. The women in the control arm of the study treated with the approved drugs doxorubicine or topetecan reported a median survival time of 13.6 months.
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