Bayer/Onyx BAY 43-9006 Interim Analysis To Support Accelerated NDA Filing
This article was originally published in Pharmaceutical Approvals Monthly
Onyx expects its kidney cancer therapy BAY 43-9006 to receive accelerated approval by 2006 based on initial Phase III data showing statistically significantly longer progression-free survival versus placebo
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Bayer and Onyx expect to launch their renal cell carcinoma therapy BAY 43-9006 (sorafenib) in the first half of 2006
Bayer/Onyx plan to wait for Phase III overall survival results for their kidney cancer agent BAY 43-9006 instead of moving forward with submission using Phase II data, which will push launch projections back to 2006. Bayer outlined a plan to file based on the Phase II results when the data was presented at the American Society of Clinical Oncology meeting in June. The firms expect to enroll 800 renal cell carcinoma patients in the Phase III trial of the RAF kinase inhibitor, now underway. The trial "was initiated after a special protocol assessment was completed by the FDA in the fourth quarter of 2003," Onyx says Oct. 25...
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