Bayer/Onyx, Pfizer Submit NDAs For Fast-Track Kidney Cancer Agents
This article was originally published in Pharmaceutical Approvals Monthly
Bayer and Onyx expect to launch their renal cell carcinoma therapy BAY 43-9006 (sorafenib) in the first half of 2006
You may also be interested in...
Bayer/Onyx' interim analysis of a pivotal renal cell carcinoma trial of Nexavar (sorafenib), conducted after placebo-treated patients crossed over to Nexavar, finds that the oral multi-kinase inhibitor "did not reach statistical significance (p<0.0005)," the firms say Nov. 3. Nevertheless, "these early results suggest a favorable survival trend." Based on the cross-over analysis, "there was an estimated 39% improvement in survival for patients receiving Nexavar versus those receiving placebo (p=0.018; hazard ratio=0.72)." The analysis was based on 220 survival events (patient deaths), while the final analysis is planned "when 540 events have occurred." The Nexavar NDA, submitted July 11, is based on 24-week data from the trial, in which a highly statistically significant progression-free survival benefit was seen (1Pharmaceutical Approvals Monthly August 2005, p. 14)...
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
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011