Abbott Atrasentan Meta-Analysis Of Failed Trials Is "Centerpiece" Of NDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Abbott will complete the NDA filing for Xinlay (atrasentan) in metastatic hormone-refractory prostate cancer by year-end, ahead of the 2005 timetable predicted after its pivotal trial in the indication failed to reach statistical significance.
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Year-End 2004 Submissions Slow; FDA Returns To Boom In Approvals
Year-end submissions are down, but end-of-year approvals are up at 15 versus six in 2003. December 2004 saw 14 filings compared to 17 a year ago. Submission slow-down reflects diminishing late-stage pipelines across industry; only five of the end-of-year filings were for new molecular entities
Year-End 2004 Submissions Slow; FDA Returns To Boom In Approvals
Year-end submissions are down, but end-of-year approvals are up at 15 versus six in 2003. December 2004 saw 14 filings compared to 17 a year ago. Submission slow-down reflects diminishing late-stage pipelines across industry; only five of the end-of-year filings were for new molecular entities
Abbott axes atrasentan trial
Abbott ends Phase III trial of atrasentan for end-stage prostate cancer after preliminary analysis fails to meet the primary endpoint of time to disease progression (a composite including the need for pain medication, chemotherapy or radiation and progression of cancer in bone). The selective endothelin-A receptor antagonist did yield improvements in development of bone pain as an adverse event, prostate-specific antigen levels and biochemical markers of skeletal progression. Study M00-211 enrolled 810 men with advanced metastatic hormone-refractory prostate cancer. Abbott will continue its second Phase III atrasentan trial, which is assessing the drug in men with less advanced, non-metastatic prostate cancer. Also continuing is a 200-patient Phase II study of men with rising PSA following prostate cancer surgery. The firm plans additional studies in earlier prostate cancer, renal cell carcinoma, ovarian, breast, brain, colorectal and non-small cell lung cancer