In what is seen as a serious setback for Abbott Laboratories, the Oncology Drug Advisory Committee (ODAC) to the US Food and Drug Administration (FDA) advised against the approval of Xinlay (atrasentan), an experimental drug for prostate cancer. Abbott was hoping Xinlay would become a blockbuster (big-selling drug). The panel were concerned about lack of clear efficacy evidence, they also wondered about its cardiovascular safety.
The panel, in its report, mentioned some protocol violations.
Abbot disagreed, saying the benefits are great while the safety profile is manageable.
Abbott says it is hopeful the FDA’s final decision may be different. Historically, the agency tends to go by what the panel has recommended.
In a statement, Abbott said “Abbott respects the committee’s vote on Xinlay today; however, we continue to believe that Xinlay represents an important option for patients with advanced prostate cancer who currently have limited options,” said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. “The company is encouraged by committee member statements regarding the activity of Xinlay and the value of continuing development of the drug. We await FDA’s decision on Xinlay.”
Dr. Joel Nelson, professor and chairman of urology, University of Pittsburgh School of Medicine said, “Eighty-five percent of the men with hormone-refractory prostate cancer have disease that spreads to the bone. Debilitating bone pain is the cardinal symptom of this stage of the disease and there are currently limited choices to delay this in men.”
Written by
Christian Nordqvist
Editor – Medical News Today