Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.An independent data monitoring committee has concluded that Bayer Pharmaceuticals and Onyx Pharmaceuticals' pivotal phase III trial of BAY 43-9006 in advanced kidney cancer met its surrogate endpoint in delaying disease progression.
Subscribe to our email newsletter
The committee review found that statistically significant longer progression-free survival was achieved in those patients administered BAY 43-9006 versus those patients administered placebo. As a result of this favorable outcome, Bayer and Onyx plan to prepare a new drug application (NDA) to submit to the FDA for possible accelerated approval in the US.
As previously agreed with the FDA, the two companies will continue the phase III study as originally planned to its primary endpoint of overall survival.
The multi-national, placebo-controlled phase III study recently finished enrolling over 800 patients with advanced kidney cancer. The primary endpoint of the study is overall survival, with disease progression, overall response rate, and safety also being assessed.
BAY 43-9006 has demonstrated both anti-proliferative and anti-angiogenic properties – two important anticancer activities.