New hypothesis = new trials

Members of FDA's Oncologic Drugs Advisory Committee had a message last week for companies whose trials don't show clear results: it's fine to do data-dredging, but finding a subset of patients who might respond to a compound is not a basis for approval. Instead, the new hypotheses must be tested in additional trials. This message should hardly be surprising, but companies apparently need to be constantly reminded of it.

The panel was considering prostate cancer compound Xinlay atrasentan from Abbott Laboratories. ABT (Abbott Park, Ill.) is seeking approval of Xinlay, a small molecule selective endothelin A receptor antagonist, to treat metastatic hormone-refractory prostate cancer in men with confirmed bone metastases...