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news.An advisory panel to the FDA has dealt a blow to Abbott Laboratories having refused to recommend the approval of its oral investigational agent Xinlay for the treatment of prostate cancer that has spread to the bone.
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The advisory committee chose not to recommend Xinlay (atrasentan) for the treatment of patients with hormone-refractory prostate cancer (HRPC) that has spread to the bone but did say that they encouraged further development of the product.
“Abbott respects the committee’s vote on Xinlay; 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, vice president, global pharmaceutical clinical development, Abbott.
Mr Sun continued: “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.”
Xinlay is an investigational, oral, once-daily, non-hormonal, non- chemotherapy, agent that belongs to a class of compounds known as selective endothelin-A receptor antagonists (SERA). SERAs antagonize the effect of endothelin-l (ET-l), one of the proteins thought to be involved in the stimulation of the growth and spread of cancer cells.
Abbott submitted a new drug application in December 2004, supplying Xinlay data which showed time to disease progression and delay in time to onset of bone pain.
Xinlay is being studied in earlier stage prostate cancer patients in an ongoing phase III study in hormone-refractory prostate cancer patients without metastasis. This study to expected to be complete in 2006.