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FDA puts hold on GenVec TNFerade

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

GenVec's gene-based oncologicTNFerade is on clinical hold after a possible increased risk of blood clots is seen in interim results of a Phase II esophageal cancer study. In the 24-patient trial, three of eight patients receiving the highest dose developed pulmonary embolism, one of whom died. Investigators judged the death "possibly related to TNFerade and underlying disease." The interim data were presented Oct. 1 at the European Organization for Research & Treatment of Cancer meeting in Geneva, Switzerland. GenVec plans to provide FDA with additional data, the firm said Oct. 7. In addition to esophageal cancer, GenVec's Phase II TNFerade program is looking at locally advanced pancreatic and rectal cancers...

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