FDA committee: Approval of metastatic prostate Ca drug not recommended

September 19, 2005

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 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.