News: Xinlay Application Rejected
Posted September 20, 2005

In a hearing September 12th, the Oncologic Drugs Advisory Committee, an independent review panel for the FDA, rejected an application from Abbott Laboratories for approval of the experimental prostate cancer drug, atrasentan (XinlayTM). The FDA will make the final decision later, but the agency usually follows the recommendations from the advisory panels.

Abbott submitted the application based on "the weight of evidence suggests that (Xinlay) provides measurable clinical benefit with a manageable safety profile." Xinlay is an oral, once-a-day drug that targets a protein called endothelin receptor A, which is believed to help cancer cells spread.

A U.S. Food and Drug Administration preliminary staff report concluded that Abbott did not provide clear evidence of effectiveness for the drug. The report stated that “two studies of Xinlay failed to show the drug slowed progression of advanced prostate cancer”. The report also indicated that Xinlay raised "serious cardiovascular safety issues”. The report is posted on the FDA's Web site at: http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4174B1-00-index-with-disclaimer.htm

Abbott presented an argument saying that pooling data from the trials demonstrated Xinlay delayed the disease's spread and reduced pain from the disease's spread to the bone. Abbott said the cardiovascular problems were infrequent and that patients at risk for heart failure could be monitored for the complication, which can be treated with medication.

Six members of the prostate cancer community, including PCRI’s Harry Pinchot, addressed the Committee to support approval. The others were: Bill Blair and Jim Kiefert of UsTOO, Jim Waldenfels, Ed Grove and Kathy Meade of the Virginia Prostate Cancer Coalition. Dr. Joseph Kuntze from California also addressed the panel on behalf of his patients. The audience of around 200 included about 20 prostate cancer survivors and was comprised mostly of members of the press and the investment community.

The company has stated that the current clinical trials and the Extended Access programs are continuing.

Prostate Cancer Research Institute (PCRI)
 

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