FDA committee: Approval of metastatic prostate Ca drug not recommended

The FDA's Oncology Drug Advisory Committee has not recommended approval of atrasentan (Xinlay), an oral agent for the treatment of metastatic hormone-refractory prostate cancer. The drug is a once-daily, non-hormonal, non-chemotherapy selective endothelin-A receptor antagonist, which is currently being studied in an ongoing phase III trial in hormone-refractory prostate cancer patients without metastasis. The study is expected to be completed in 2006.