Abbott Xinlay "not approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Abbott's selective endothelin-A receptor antagonist Xinlay (atrasentan) is "not approvable" Oct. 13 for metastatic, hormone refractory prostate cancer (HRPC). FDA's decision follows a unanimous recommendation against Xinlay approval by the agency's Oncologic Drugs Advisory Committee Sept. 13 (1Pharmaceutical Approvals Monthly October 2005, p. 3). Abbott's NDA is based on a post hoc meta-analysis of subgroups in two failed pivotal trials; the firm has suggested non-metastatic HRPC as a potential alternative pathway for Xinlay...